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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88491

12 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 11, 2021
Product types
Device
Classifications
Class II
Statuses
Completed
Recalling firm wording
Philips North America Llc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

12 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 12

Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781341 781396

Z-2411-2021
Recall number
Z-2411-2021
Initiated
August 11, 2021
Classification
Class II
Status
Completed
Recalling firm
Philips North America Llc
Quantity
1517 units, 488 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment

Code information

Model: 781341 Serial Number Unique Device Identifier (UDI#) 70085 N/A 70160 N/A 70246 N/A 70349 N/A 70348 N/A 70407 N/A 70723 N/A 70873 N/A 70917 N/A 87101 (01)00884838055322(21)87101 70040 N/A 70229 N/A 70607 N/A 70763 N/A 84126 (01)00884838055322(21)84126 84030 (01)00884838055322(21)84030 84108 (01)00884838055322(21)84108 84234 (01)00884838055322(21)84234 84257 N/A 84596 (01)00884838055322(21)84596 87005 (01)00884838055322(21)87005 87146 (01)00884838055322(21)87146 70279 N/A 70367 N/A 70374 N/A 70375 N/A 70461 N/A 70471 N/A 70742 N/A 70764 N/A 70064 N/A 70113 N/A 70604 N/A 70603 N/A 70605 N/A 70725 N/A 70704 N/A 70768 N/A 70794 N/A 70766 N/A 70812 N/A 70767 N/A 84539 (01)00884838055322(21)84539 70780 N/A 84566 (01)00884838055322(21)84566 84621 (01)00884838055322(21)84621 84667 (01)00884838055322(21)84667 84629 (01)00884838055322(21)84629 84962 (01)00884838055322(21)84962 87214 (01)00884838055322(21)87214 87215 (01)00884838055322(21)87215 70071 N/A 70284 N/A 70311 N/A 70916 N/A 84098 (01)00884838055322(21)84098 84343 (01)00884838055322(21)84343 84249 (01)00884838055322(21)84249 84891 (01)00884838055322(21)84891 84765 (01)00884838055322(21)84765 70110 N/A 70111 N/A 70177 N/A 70161 N/A 70204 N/A 70205 N/A 70244 N/A 70269 N/A 70088 N/A 70446 N/A 70448 N/A 70470 N/A 70665 N/A 70678 N/A 70459 N/A 70755 N/A 70666 N/A 70664 N/A 70663 N/A 70667 N/A 70668 N/A 70662 N/A 70864 N/A 70845 N/A 70943 N/A 70942 N/A 70866 N/A 70868 N/A 70867 N/A 70969 N/A 70691 N/A 70612 (01)00884838055322(21)70612 84178 (01)00884838055322(21)84178 84179 (01)00884838055322(21)84179 84180 (01)00884838055322(21)84180 84300 (01)00884838055322(21)84300 84302 (01)00884838055322(21)84302 84381 (01)00884838055322(21)84381 84330 (01)00884838055322(21)84330 84303 (01)00884838055322(21)84303 84385 (01)00884838055322(21)84622 84384 (01)00884838055322(21)84384 84387 (01)00884838055322(21)84387 84451 (01)00884838055322(21)84451 84976 (01)00884838055322(21)84976 87028 (01)00884838055322(21)87028 84844 (01)00884838055322(21)84844 87271 (01)00884838055322(21)87271 84622 (01)00884838055322(21)84385 87040 (01)00884838055322(21)87040 87061 (01)00884838055322(21)87061 87098 (01)00884838055322(21)87098 87124 (01)00884838055322(21)87124 87125 (01)00884838055322(21)87125 87126 (01)00884838055322(21)87126 87180 (01)00884838055322(21)87180 87206 (01)00884838055322(21)87206 87207 (01)00884838055322(21)87207 87221 (01)00884838055322(21)87221 87222 (01)00884838055322(21)87222 70488 N/A 70832 N/A 70286 N/A 70221 N/A 70655 N/A 70641 N/A 70730 N/A 70712 N/A 70858 N/A 70851 N/A 84644 (01)00884838055322(21)84644 84649 (01)00884838055322(21)84649 70067 N/A 70074 N/A 70101 N/A 70114 N/A 70104 N/A 70073 N/A 70009 N/A 70278 N/A 70206 N/A 70306 N/A 70452 N/A 70623 N/A 70622 N/A 70590 N/A 70589 N/A 70588 N/A 70696 N/A 70705 N/A 70754 N/A 84042 N/A 70869 N/A 70975 (01)00884838055322(21)70975 84084 (01)00884838055322(21)84084 84203 (01)00884838055322(21)84203 84315 (01)00884838055322(21)84315 84555 (01)00884838055322(21)84555 84268 (01)00884838055322(21)84268 84788 N/A 87027 (01)00884838055322(21)87027 70424 N/A 84092 (01)00884838055322(21)84092 84311 (01)00884838055322(21)84311 84766 (01)00884838055322(21)84766 84744 (01)00884838055322(21)84744 84890 (01)00884838055322(21)84890 84730 (01)00884838055322(21)84730 84986 (01)00884838055322(21)84986 84982 (01)00884838055322(21)84982 87151 (01)00884838055322(21)87151 87171 (01)00884838055322(21)87171 87191 (01)00884838055322(21)87191 84010 N/A 70981 N/A 84082 N/A 84110 (01)00884838055322(21)84110 70997 (01)00884838055322(21)70997 84066 (01)00884838055322(21)84066 84197 (01)00884838055322(21)84197 70974 (01)00884838055322(21)70974 84150 (01)00884838055322(21)84150 84204 (01)00884838055322(21)84204 84242 (01)00884838055322(21)84242 70987 (01)00884838055322(21)70987 84230 (01)00884838055322(21)84230 84262 (01)00884838055322(21)84262 84291 (01)00884838055322(21)84291 84256 N/A 84290 (01)00884838055322(21)84290 84310 (01)00884838055322(21)84310 84287 (01)00884838055322(21)84287 84321 (01)00884838055322(21)84321 84318 (01)00884838055322(21)84318 84320 (01)00884838055322(21)84320 84383 (01)00884838055322(21)84383 84327 (01)00884838055322(21)84327 84397 (01)00884838055322(21)84397 84503 (01)00884838055322(21)84503 84411 (01)00884838055322(21)84411 84452 (01)00884838055322(21)84452 84328 (01)00884838055322(21)84328 84417 (01)00884838055322(21)84417 84307 (01)00884838055322(21)84307 84414 (01)00884838055322(21)84414 84515 (01)00884838055322(21)84515 84496 (01)00884838055322(21)84496 84582 (01)00884838055322(21)84582 84497 (01)00884838055322(21)84497 84585 (01)00884838055322(21)84585 84695 (01)00884838055322(21)84695 84427 (01)00884838055322(21)84427 84422 (01)00884838055322(21)84422 84591 (01)00884838055322(21)84591 84399 (01)00884838055322(21)84399 84756 (01)00884838055322(21)84756 84597 N/A 84645 (01)00884838055322(21)84645 84787 (01)00884838055322(21)84787 84686 (01)00884838055322(21)84686 84736 (01)00884838055322(21)84736 84531 (01)00884838055322(21)84531 84640 (01)00884838055322(21)84640 84755 (01)00884838055322(21)84755 84723 (01)00884838055322(21)84723 84655 (01)00884838055322(21)84655 84770 (01)00884838055322(21)84770 84673 (01)00884838055322(21)84673 84389 N/A 84668 (01)00884838055322(21)84668 84525 (01)00884838055322(21)84525 84812 (01)00884838055322(21)84812 84795 (01)00884838055322(21)84795 84813 (01)00884838055322(21)84813 84588 (01)00884838055322(21)84588 84842 (01)00884838055322(21)84842 84810 (01)00884838055322(21)84810 84822 (01)00884838055322(21)84822 84833 (01)00884838055322(21)84833 84532 (01)00884838055322(21)84532 84857 (01)00884838055322(21)84857 84861 (01)00884838055322(21)84861 84608 (01)00884838055322(21)84608 84837 (01)00884838055322(21)84837 84863 (01)00884838055322(21)84863 84845 (01)00884838055322(21)84845 84881 (01)00884838055322(21)84881 84872 (01)00884838055322(21)84872 84831 (01)00884838055322(21)84831 84882 (01)00884838055322(21)84882 84922 (01)00884838055322(21)84922 84909 (01)00884838055322(21)84909 84928 (01)00884838055322(21)84928 84947 (01)00884838055322(21)84947 84917 (01)00884838055322(21)84917 84855 (01)00884838055322(21)84855 84965 (01)00884838055322(21)84965 84905 (01)00884838055322(21)84905 87009 (01)00884838055322(21)87009 84984 (01)00884838055322(21)84984 84990 (01)00884838055322(21)84990 84859 (01)00884838055322(21)84859 87029 (01)00884838055322(21)87029 84830 (01)00884838055322(21)84830 87054 (01)00884838055322(21)87054 87048 (01)00884838055322(21)87048 87045 (01)00884838055322(21)87045 87109 (01)00884838055322(21)87109 87123 (01)00884838055322(21)87123 87084 (01)00884838055322(21)87084 87110 (01)00884838055322(21)87110 87062 (01)00884838055322(21)87062 87065 (01)00884838055322(21)87065 87174 (01)00884838055322(21)87174 84997 (01)00884838055322(21)84997 84692 (01)00884838055322(21)84692 84946 (01)00884838055322(21)84946 87192 (01)00884838055322(21)87192 87202 (01)00884838055322(21)87202 87201 (01)00884838055322(21)87201 84943 (01)00884838055322(21)84943 87233 (01)00884838055322(21)87233 87056 (01)00884838055322(21)87056 87142 (01)00884838055322(21)87142 87224 (01)00884838055322(21)87224 87240 (01)00884838055322(21)87240 87227 (01)00884838055322(21)87227 87241 (01)00884838055322(21)87241 87254 (01)00884838055322(21)87254 84153 N/A 84542 N/A 84551 (01)00884838055322(21)84551 87112 (01)00884838055322(21)87112 70333 N/A 70369 N/A 70778 N/A 70803 N/A 70980 N/A 70965 N/A 84195 (01)00884838055322(21)84195 84408 (01)00884838055322(21)84408 84407 (01)00884838055322(21)84407 84547 (01)00884838055322(21)84547 84669 (01)00884838055322(21)84669 84687 (01)00884838055322(21)84687 87058 (01)00884838055322(21)87058 70029 N/A 70021 N/A 70046 N/A 70099 N/A 70129 N/A 70199 N/A 70202 N/A 70233 N/A 70289 N/A 70223 N/A 70294 N/A 70302 N/A 70232 N/A 70277 N/A 70313 N/A 70376 N/A 70381 N/A 70427 N/A 70463 N/A 70583 N/A 70626 N/A 70680 N/A 70692 N/A 70679 N/A 70464 N/A 70611 N/A 70596 N/A 70785 N/A 70784 N/A 70684 N/A 70660 N/A 70854 N/A 70870 N/A 70948 N/A 70799 N/A 70921 N/A 70881 N/A 70855 N/A 70986 (01)00884838055322(21)70986 70993 (01)00884838055322(21)70993 70992 (01)00884838055322(21)70992 70886 (01)00884838055322(21)70886 84187 (01)00884838055322(21)84187 84104 (01)00884838055322(21)84104 84131 (01)00884838055322(21)84131 84122 (01)00884838055322(21)84122 84207 (01)00884838055322(21)84207 84016 (01)00884838055322(21)84016 84228 (01)00884838055322(21)84228 84116 (01)00884838055322(21)84116 84259 (01)00884838055322(21)84259 84388 (01)00884838055322(21)84388 84423 N/A 84453 (01)00884838055322(21)84453 84454 (01)00884838055322(21)84454 84557 (01)00884838055322(21)84557 84544 (01)00884838055322(21)84544 84624 (01)00884838055322(21)84624 84564 N/A 84565 (01)00884838055322(21)84565 84574 (01)00884838055322(21)84574 84725 (01)00884838055322(21)84725 84632 (01)00884838055322(21)84632 84718 (01)00884838055322(21)84718 84652 (01)00884838055322(21)84652 84829 (01)00884838055322(21)84829 84914 (01)00884838055322(21)84914 84939 (01)00884838055322(21)84939 84996 (01)00884838055322(21)84996 87252 (01)00884838055322(21)87252 87249 (01)00884838055322(21)87249 84107 (01)00884838055322(21)84107 84654 (01)00884838055322(21)84654 70032 N/A 70249 N/A 70250 N/A 70258 N/A 84093 (01)00884838055322(21)84093 84136 (01)00884838055322(21)84136 84141 (01)00884838055322(21)84141 84202 (01)00884838055322(21)84202 84488 (01)00884838055322(21)84488 87141 (01)00884838055322(21)87141 84664 (01)00884838055322(21)84664 70601 N/A 87008 (01)00884838055322(21)87008 84704 (01)00884838055322(21)84704 84705 (01)00884838055322(21)84705 70296 N/A 70597 N/A 70818 N/A 70885 N/A 70976 N/A 84051 N/A 84166 (01)00884838055322(21)84166 84175 (01)00884838055322(21)84175 84176 (01)00884838055322(21)84176 84164 (01)00884838055322(21)84164 70991 (01)00884838055322(21)70991 84167 (01)00884838055322(21)84167 84165 (01)00884838055322(21)84165 84323 (01)00884838055322(21)84323 84322 (01)00884838055322(21)84322 84342 (01)00884838055322(21)84342 84425 (01)00884838055322(21)84425 84471 (01)00884838055322(21)84471 84593 (01)00884838055322(21)84593 84742 (01)00884838055322(21)84742 87139 (01)00884838055322(21)87139 87247 (01)00884838055322(21)87247 70123 N/A 70226 N/A 70251 N/A 70295 N/A 70364 N/A 70344 N/A 70435 N/A 70656 N/A 70629 N/A 70846 N/A 70787 N/A 70890 N/A 84004 N/A 84205 (01)00884838055322(21)84205 84312 (01)00884838055322(21)84312 84332 (01)00884838055322(21)84332 84442 (01)00884838055322(21)84442 84476 (01)00884838055322(21)84476 84313 (01)00884838055322(21)84313 84568 (01)00884838055322(21)84568 84576 (01)00884838055322(21)84576 84584 (01)00884838055322(21)84584 84378 (01)00884838055322(21)84378 84592 (01)00884838055322(21)84592 84663 (01)00884838055322(21)84663 84773 (01)00884838055322(21)84773 84774 (01)00884838055322(21)84774 84371 (01)00884838055322(21)84371 84740 (01)00884838055322(21)84740 84549 (01)00884838055322(21)84549 84896 (01)00884838055322(21)84896 87039 (01)00884838055322(21)87039 87119 (01)00884838055322(21)87119 87004 (01)00884838055322(21)87004 87134 (01)00884838055322(21)87134 87034 (01)00884838055322(21)87034 70235 N/A 70383 N/A 70796 N/A 84412 (01)00884838055322(21)84412 70043 N/A 70068 N/A 70270 N/A 70239 N/A 70228 N/A 70312 N/A 70321 N/A 70276 N/A 70598 N/A 70651 N/A 70683 N/A 70708 N/A 70673 N/A 70617 N/A 70593 N/A 70738 N/A 70709 N/A 70630 N/A 70737 N/A 70865 N/A 70860 N/A 70889 N/A 70929 N/A 70844 N/A 70927 N/A 70938 N/A 70973 N/A 70908 N/A 70966 N/A 84011 (01)00884838055322(21)84011 70989 (01)00884838055322(21)70989 84109 (01)00884838055322(21)84109 84102 (01)00884838055322(21)84102 84238 (01)00884838055322(21)84238 84199 (01)00884838055322(21)84199 84224 (01)00884838055322(21)84224 84248 (01)00884838055322(21)84248 84226 (01)00884838055322(21)84226 84250 (01)00884838055322(21)84250 84341 (01)00884838055322(21)84341 84271 (01)00884838055322(21)84271 84409 N/A 84473 (01)00884838055322(21)84473 84474 (01)00884838055322(21)84474 84533 (01)00884838055322(21)84533 84517 (01)00884838055322(21)84517 84528 (01)00884838055322(21)84528 84437 (01)00884838055322(21)84437 84490 (01)00884838055322(21)84490 84546 (01)00884838055322(21)84546 84560 (01)00884838055322(21)84560 84435 (01)00884838055322(21)84435 84550 (01)00884838055322(21)84550 84459 (01)00884838055322(21)84459 84516 (01)00884838055322(21)84516 84554 (01)00884838055322(21)84554 84569 (01)00884838055322(21)84569 84671 (01)00884838055322(21)84671 84630 (01)00884838055322(21)84630 84681 (01)00884838055322(21)84681 84850 (01)00884838055322(21)84850 84867 (01)00884838055322(21)84867 84910 (01)00884838055322(21)84910 84807 (01)00884838055322(21)84807 84920 (01)00884838055322(21)84920 84825 (01)00884838055322(21)84825 87076 (01)00884838055322(21)87076 84921 (01)00884838055322(21)84921 70401 N/A 70301 N/A 70093 N/A 70144 N/A 70148 N/A 70191 N/A 70297 N/A 70245 N/A 70316 N/A 70451 N/A 70453 N/A 70482 N/A 70429 N/A 70608 N/A 70440 N/A 70472 N/A 70587 N/A 70465 N/A 70770 N/A 70872 N/A 70887 N/A 70843 N/A 70761 N/A 70899 N/A 70906 N/A 70923 N/A 70994 N/A 84005 N/A 84038 N/A 84068 (01)00884838055322(21)84068 84085 (01)00884838055322(21)84085 84137 (01)00884838055322(21)84137 70914 (01)00884838055322(21)70914 84154 (01)00884838055322(21)84154 84208 (01)00884838055322(21)84208 84252 (01)00884838055322(21)84252 84185 (01)00884838055322(21)84185 84253 (01)00884838055322(21)84253 84297 (01)00884838055322(21)84297 84293 (01)00884838055322(21)84293 84231 (01)00884838055322(21)84231 84210 (01)00884838055322(21)84210 84306 (01)00884838055322(21)84306 84392 (01)00884838055322(21)84392 84377 (01)00884838055322(21)84377 84295 (01)00884838055322(21)84295 84448 (01)00884838055322(21)84448 84406 (01)00884838055322(21)84406 84334 (01)00884838055322(21)84334 84346 (01)00884838055322(21)84346 84445 (01)00884838055322(21)84445 84325 (01)00884838055322(21)84325 84429 (01)00884838055322(21)84429 84450 (01)00884838055322(21)84450 84694 (01)00884838055322(21)84694 84690 (01)00884838055322(21)84690 84768 (01)00884838055322(21)84768 84803 (01)00884838055322(21)84803 84838 (01)00884838055322(21)84838 84272 (01)00884838055322(21)84272 84869 (01)00884838055322(21)84869 84750 (01)00884838055322(21)84750 87081 (01)00884838055322(21)87081 87083 (01)00884838055322(21)87083 87121 (01)00884838055322(21)87121 87195 (01)00884838055322(21)87195 87194 (01)00884838055322(21)87194 87228 (01)00884838055322(21)87228 70760 N/A 87186 (01)00884838055322(21)87186 70599 N/A 84801 (01)00884838055322(21)84801 84900 (01)00884838055322(21)84900 84901 (01)00884838055322(21)84901 70347 N/A 70648 N/A 70797 N/A 84047 N/A 84489 (01)00884838055322(21)84489 84581 (01)00884838055322(21)84581 84789 (01)00884838055322(21)84789 87059 (01)00884838055322(21)87059 87111 (01)00884838055322(21)87111 70654 N/A 84792 (01)00884838055322(21)84792 70804 N/A 84806 (01)00884838055322(21)84806 84218 (01)00884838055322(21)84218 70072 N/A 70613 N/A 70934 N/A 70146 N/A 70201 N/A 70287 N/A 70281 N/A 70658 N/A 70645 N/A 70751 N/A 70880 N/A 84015 N/A 84212 (01)00884838055322(21)84212 84267 (01)00884838055322(21)84267 87068 (01)00884838055322(21)87068 70119 N/A 70280 N/A 70339 N/A 70361 N/A 70425 N/A 70717 N/A 70773 N/A 70933 N/A 70931 N/A 70932 N/A 70962 N/A 84095 (01)00884838055322(21)84095 84096 (01)00884838055322(21)84096 84070 (01)00884838055322(21)84070 84241 (01)00884838055322(21)84241 84245 (01)00884838055322(21)84245 84292 (01)00884838055322(21)84292 84298 (01)00884838055322(21)84298 84401 (01)00884838055322(21)84401 84372 (01)00884838055322(21)84372 84421 (01)00884838055322(21)84421 84375 N/A 84524 (01)00884838055322(21)84524 84523 (01)00884838055322(21)84523 84518 (01)00884838055322(21)84518 84520 (01)00884838055322(21)84520 84374 N/A 84680 (01)00884838055322(21)84680 84676 (01)00884838055322(21)84676 84455 (01)00884838055322(21)84455 84678 (01)00884838055322(21)84678 84598 (01)00884838055322(21)84598 84679 (01)00884838055322(21)84679 84693 (01)00884838055322(21)84693 84522 (01)00884838055322(21)84522 84757 (01)00884838055322(21)84757 84458 (01)00884838055322(21)84458 84677 (01)00884838055322(21)84677 84519 (01)00884838055322(21)84519 84657 (01)00884838055322(21)84657 84521 (01)00884838055322(21)84521 84832 (01)00884838055322(21)84832 87000 (01)00884838055322(21)87000 84456 (01)00884838055322(21)84456 84477 (01)00884838055322(21)84477 87155 (01)00884838055322(21)87155 87131 (01)00884838055322(21)87131 87129 (01)00884838055322(21)87129 87213 (01)00884838055322(21)87213 70196 N/A 70334 N/A 70335 N/A 70703 N/A 70384 N/A 70918 N/A 70919 N/A 84216 (01)00884838055322(21)84216 84211 (01)00884838055322(21)84211 84209 (01)00884838055322(21)84209 84261 (01)00884838055322(21)84261 84331 (01)00884838055322(21)84331 84494 (01)00884838055322(21)84494 84719 (01)00884838055322(21)84719 84720 (01)00884838055322(21)84720 84617 N/A 70423 N/A 70069 N/A 70027 N/A 70103 N/A 70102 N/A 70227 N/A 70290 N/A 70304 N/A 70300 N/A 70256 N/A 70444 N/A 70483 N/A 70639 N/A 70585 N/A 70687 N/A 70644 N/A 70592 N/A 70671 N/A 70591 N/A 70726 N/A 70480 N/A 70728 N/A 70642 N/A 70746 N/A 70786 N/A 70750 N/A 70757 N/A 70795 N/A 70765 N/A 70798 N/A 70817 N/A 70809 N/A 70834 N/A 70823 N/A 70821 N/A 70702 N/A 70935 N/A 70946 N/A 70961 N/A 70971 N/A 70826 N/A 70988 N/A 84017 N/A 84041 (01)00884838055322(21)84041 84007 (01)00884838055322(21)84007 84076 (01)00884838055322(21)84076 84097 (01)00884838055322(21)84097 84080 (01)00884838055322(21)84080 84135 (01)00884838055322(21)84135 84091 (01)00884838055322(21)84091 84081 (01)00884838055322(21)84081 84083 (01)00884838055322(21)84083 84177 (01)00884838055322(21)84177 70957 (01)00884838055322(21)70957 84127 (01)00884838055322(21)84127 84125 (01)00884838055322(21)84125 84124 (01)00884838055322(21)84124 84220 (01)00884838055322(21)84220 84269 (01)00884838055322(21)84269 84294 (01)00884838055322(21)84294 84368 (01)00884838055322(21)84368 84382 (01)00884838055322(21)84382 84413 (01)00884838055322(21)84413 84420 (01)00884838055322(21)84420 84281 (01)00884838055322(21)84281 84431 (01)00884838055322(21)84431 84144 (01)00884838055322(21)84144 84329 (01)00884838055322(21)84329 84491 (01)00884838055322(21)84491 84502 (01)00884838055322(21)84502 84513 (01)00884838055322(21)84513 84507 (01)00884838055322(21)84507 84530 (01)00884838055322(21)84530 84536 (01)00884838055322(21)84536 84606 (01)00884838055322(21)84606 84541 (01)00884838055322(21)84541 84594 (01)00884838055322(21)84594 84604 (01)00884838055322(21)84604 84804 (01)00884838055322(21)84804 84864 (01)00884838055322(21)84864 84871 (01)00884838055322(21)84871 84952 (01)00884838055322(21)84952 84851 (01)00884838055322(21)84851 84893 (01)00884838055322(21)84893 84988 (01)00884838055322(21)84988 84995 (01)00884838055322(21)84995 87165 (01)00884838055322(21)87165 87092 (01)00884838055322(21)87092 87115 (01)00884838055322(21)87115 84956 (01)00884838055322(21)84956 84275 (01)00884838055322(21)84275 84826 (01)00884838055322(21)84826 84940 (01)00884838055322(21)84940 87210 (01)00884838055322(21)87210 84086 (01)00884838055322(21)84086 70038 N/A 70056 N/A 70037 N/A 70036 N/A 70011 N/A 70013 N/A 70039 N/A 70053 N/A 70055 N/A 70122 N/A 70084 N/A 70142 N/A 70192 N/A 70203 N/A 70263 N/A 70299 N/A 70329 N/A 70273 N/A 70379 N/A 70436 N/A 70441 N/A 70460 N/A 70454 N/A 70595 N/A 70484 N/A 70432 N/A 70670 N/A 70649 N/A 70682 N/A 70732 N/A 70734 N/A 70741 N/A 70647 N/A 70720 N/A 70735 N/A 70736 N/A 70792 N/A 70774 N/A 70747 N/A 70800 N/A 70789 N/A 70813 N/A 70805 N/A 70772 N/A 70827 N/A 70839 N/A 70824 N/A 70820 N/A 70825 N/A 70848 N/A 70859 N/A 70902 N/A 70836 N/A 70850 N/A 70876 N/A 70909 N/A 70920 N/A 70970 N/A 70926 N/A 84008 N/A 84027 N/A 84034 N/A 70979 (01)00884838055322(21)70979 84031 N/A 84018 N/A 84028 N/A 84052 N/A 84048 N/A 84035 (01)00884838055322(21)84035 84099 (01)00884838055322(21)84099 70861 (01)00884838055322(21)70861 84061 (01)00884838055322(21)84061 84062 (01)00884838055322(21)84062 84065 (01)00884838055322(21)84065 84032 (01)00884838055322(21)84032 84079 (01)00884838055322(21)84079 84172 (01)00884838055322(21)84172 84118 (01)00884838055322(21)84118 84162 (01)00884838055322(21)84162 84060 (01)00884838055322(21)84060 84201 (01)00884838055322(21)84201 84149 (01)00884838055322(21)84149 84193 (01)00884838055322(21)84193 84229 (01)00884838055322(21)84229 84233 (01)00884838055322(21)84233 84114 (01)00884838055322(21)84114 84247 (01)00884838055322(21)84247 84219 (01)00884838055322(21)84219 84194 (01)00884838055322(21)84194 84255 (01)00884838055322(21)84255 84266 (01)00884838055322(21)84266 84270 (01)00884838055322(21)84270 84309 (01)00884838055322(21)84309 84289 (01)00884838055322(21)84289 84379 (01)00884838055322(21)84379 84360 (01)00884838055322(21)84360 84333 (01)00884838055322(21)84333 84357 (01)00884838055322(21)84357 84359 (01)00884838055322(21)84359 84376 (01)00884838055322(21)84376 84335 (01)00884838055322(21)84335 84415 (01)00884838055322(21)84415 84394 (01)00884838055322(21)84394 84444 (01)00884838055322(21)84444 84510 (01)00884838055322(21)84510 84534 (01)00884838055322(21)84534 84480 (01)00884838055322(21)84480 84495 (01)00884838055322(21)84495 84500 (01)00884838055322(21)84500 84501 (01)00884838055322(21)84501 84447 (01)00884838055322(21)84447 84659 N/A 84527 (01)00884838055322(21)84527 84660 N/A 84492 (01)00884838055322(21)84492 84535 (01)00884838055322(21)84535 84545 (01)00884838055322(21)84545 84191 (01)00884838055322(21)84191 84556 (01)00884838055322(21)84556 84641 (01)00884838055322(21)84641 84603 (01)00884838055322(21)84603 84650 (01)00884838055322(21)84650 84634 (01)00884838055322(21)84634 84635 (01)00884838055322(21)84635 84722 (01)00884838055322(21)84722 84666 (01)00884838055322(21)84666 84724 (01)00884838055322(21)84724 84713 (01)00884838055322(21)84713 84706 (01)00884838055322(21)84706 84708 (01)00884838055322(21)84708 84721 (01)00884838055322(21)84721 84647 (01)00884838055322(21)84647 84697 (01)00884838055322(21)84697 84670 (01)00884838055322(21)84670 84712 (01)00884838055322(21)84712 84747 (01)00884838055322(21)84747 84790 (01)00884838055322(21)84790 84751 (01)00884838055322(21)84751 84583 (01)00884838055322(21)84583 84748 (01)00884838055322(21)84748 84714 (01)00884838055322(21)84714 84793 (01)00884838055322(21)84793 84820 (01)00884838055322(21)84820 84880 (01)00884838055322(21)84880 84839 (01)00884838055322(21)84839 84818 (01)00884838055322(21)84818 84819 (01)00884838055322(21)84819 84858 (01)00884838055322(21)84858 84873 (01)00884838055322(21)84873 84745 (01)00884838055322(21)84745 84879 (01)00884838055322(21)84879 84895 (01)00884838055322(21)84895 84904 (01)00884838055322(21)84904 84775 (01)00884838055322(21)84775 84987 (01)00884838055322(21)84987 84918 (01)00884838055322(21)84918 84930 (01)00884838055322(21)84930 84977 (01)00884838055322(21)84977 84978 (01)00884838055322(21)84978 84908 (01)00884838055322(21)84908 87001 (01)00884838055322(21)87001 87038 (01)00884838055322(21)87038 84805 (01)00884838055322(21)84805 87023 (01)00884838055322(21)87023 87066 (01)00884838055322(21)87066 87117 (01)00884838055322(21)87117 87026 (01)00884838055322(21)87026 87196 (01)00884838055322(21)87196 87197 (01)00884838055322(21)87197 87136 (01)00884838055322(21)87136 87175 (01)00884838055322(21)87175 87204 (01)00884838055322(21)87204 87235 (01)00884838055322(21)87235 87176 (01)00884838055322(21)87176 87187 (01)00884838055322(21)87187 87234 (01)00884838055322(21)87234 70343 N/A 70346 N/A 70402 N/A 84396 N/A 70891 N/A 84354 (01)00884838055322(21)84354 84349 (01)00884838055322(21)84349 84355 N/A 84351 N/A 84352 N/A 84350 (01)00884838055322(21)84350 84353 N/A 84612 (01)00884838055322(21)84612 84661 (01)00884838055322(21)84661 84847 (01)00884838055322(21)84847 87079 (01)00884838055322(21)87079 70261 N/A 70238 N/A 70128 N/A 70198 N/A 87212 (01)00884838055322(21)87212 70193 N/A 70485 N/A 70833 N/A 70831 N/A 84395 (01)00884838055322(21)84395 84404 (01)00884838055322(21)84404 84716 (01)00884838055322(21)84716 84025 (01)00884838055322(21)84025 84347 (01)00884838055322(21)84347 84772 (01)00884838055322(21)84772 84854 (01)00884838055322(21)84854 87037 (01)00884838055322(21)87037 87036 (01)00884838055322(21)87036 84443 (01)00884838055322(21)84443 84852 (01)00884838055322(21)84852 70318 N/A 70967 N/A 70930 N/A 70264 N/A 84089 (01)00884838055322(21)84089 84319 (01)00884838055322(21)84319 84221 N/A 84430 (01)00884838055322(21)84430 84600 (01)00884838055322(21)84600 84572 (01)00884838055322(21)84572 84602 (01)00884838055322(21)84602 84571 (01)00884838055322(21)84571 84700 (01)00884838055322(21)84700 84862 (01)00884838055322(21)84862 84983 (01)00884838055322(21)84983 84885 (01)00884838055322(21)84885 84834 N/A 70941 N/A 70285 N/A 70262 N/A 70638 N/A 70637 N/A 70714 N/A 70615 N/A 70862 N/A 70896 N/A 70990 N/A 70998 (01)00884838055322(21)70998 84130 (01)00884838055322(21)84130 84140 (01)00884838055322(21)84140 84138 (01)00884838055322(21)84138 84217 (01)00884838055322(21)84217 84278 (01)00884838055322(21)84278 84370 (01)00884838055322(21)84370 84419 (01)00884838055322(21)84419 84398 (01)00884838055322(21)84398 84733 (01)00884838055322(21)84733 70257 N/A 70018 N/A 70059 N/A 70303 N/A 70439 N/A 70922 N/A 70947 N/A 70960 (01)00884838055322(21)70960 84148 (01)00884838055322(21)84148 84115 (01)00884838055322(21)84115 84587 (01)00884838055322(21)84587 84752 (01)00884838055322(21)84752 87143 (01)00884838055322(21)87143 87144 (01)00884838055322(21)87144 70777 N/A 70075 N/A 70360 N/A 70131 N/A 70628 N/A 70481 N/A 70722 N/A 84145 (01)00884838055322(21)84145 84611 (01)00884838055322(21)84611 70828 N/A 84057 (01)00884838055322(21)84057 84288 (01)00884838055322(21)84288 84424 (01)00884838055322(21)84424 70136 N/A 70882 N/A 84045 N/A 84046 N/A 70022 N/A 70155 N/A 70437 N/A 70775 N/A 70830 N/A 84029 N/A 84363 (01)00884838055322(21)84363 84648 (01)00884838055322(21)84648 84605 (01)00884838055322(21)84605 84573 (01)00884838055322(21)84573 84689 (01)00884838055322(21)84689 87003 (01)00884838055322(21)87003 87102 (01)00884838055322(21)87102 70371 N/A 70236 (01)00884838055322(21)70236 70271 N/A 70937 N/A 84067 N/A 84682 (01)00884838055322(21)84682 84709 (01)00884838055322(21)84709 70048 N/A 70065 N/A 70066 N/A 70255 N/A 70711 N/A 87078 (01)00884838055322(21)87078 70282 N/A 84113 (01)00884838055322(21)84113 84888 (01)00884838055322(21)84888 70910 N/A 70416 N/A 70945 N/A 84129 (01)00884838055322(21)84129 87116 (01)00884838055322(21)87116 70759 N/A 70140 N/A 70350 N/A 70337 N/A 70351 N/A 70357 N/A 70368 N/A 70449 N/A 70456 N/A 70489 N/A 70486 N/A 70490 N/A 70686 N/A 70624 N/A 70745 N/A 70487 N/A 70744 N/A 70428 (01)00884838055322(21)70428 70847 N/A 70811 N/A 70900 N/A 70815 N/A 70840 N/A 70985 (01)00884838055322(21)70985 70954 N/A 84039 (01)00884838055322(21)84039 84171 (01)00884838055322(21)84171 84198 (01)00884838055322(21)84198 84069 (01)00884838055322(21)84069 84021 (01)00884838055322(21)84021 84244 (01)00884838055322(21)84244 84142 (01)00884838055322(21)84142 84279 (01)00884838055322(21)84279 84305 (01)00884838055322(21)84305 84361 (01)00884838055322(21)84361 84362 (01)00884838055322(21)84362 84626 (01)00884838055322(21)84626 84599 (01)00884838055322(21)84599 84662 (01)00884838055322(21)84662 84637 (01)00884838055322(21)84637 84726 (01)00884838055322(21)84726 84729 (01)00884838055322(21)84729 84738 (01)00884838055322(21)84738 84758 (01)00884838055322(21)84758 84717 (01)00884838055322(21)84717 84759 (01)00884838055322(21)84759 84796 (01)00884838055322(21)84796 84428 (01)00884838055322(21)84428 84865 (01)00884838055322(21)84865 84653 (01)00884838055322(21)84653 84931 (01)00884838055322(21)84931 84934 (01)00884838055322(21)84934 87031 (01)00884838055322(21)87031 84975 (01)00884838055322(21)84975 87024 (01)00884838055322(21)87024 84989 (01)00884838055322(21)84989 87069 (01)00884838055322(21)87069 87147 (01)00884838055322(21)87147 87188 (01)00884838055322(21)87188 87185 (01)00884838055322(21)87185 87071 (01)00884838055322(21)87071 87153 (01)00884838055322(21)87153 87154 (01)00884838055322(21)87154 87067 (01)00884838055322(21)87067 87208 (01)00884838055322(21)87208 87172 (01)00884838055322(21)87172 87211 (01)00884838055322(21)87211 87152 (01)00884838055322(21)87152 87237 (01)00884838055322(21)87237 87244 (01)00884838055322(21)87244 87161 N/A 87265 (01)00884838055322(21)87265 70092 N/A 70194 N/A 70314 N/A 70242 N/A 70776 N/A 70806 N/A 70697 N/A 70888 N/A 84087 (01)00884838055322(21)84087 70871 (01)00884838055322(21)70871 84258 (01)00884838055322(21)84258 84472 (01)00884838055322(21)84472 70878 (01)00884838055322(21)70878 84613 (01)00884838055322(21)84613 84798 (01)00884838055322(21)84798 84802 (01)00884838055322(21)84802 84746 (01)00884838055322(21)84746 87049 (01)00884838055322(21)87049 87044 (01)00884838055322(21)87044 87035 (01)00884838055322(21)87035 87090 (01)00884838055322(21)87090 87082 (01)00884838055322(21)87082 87093 (01)00884838055322(21)87093 70026 N/A 70652 N/A 70829 N/A 70995 (01)00884838055322(21)70995 70996 (01)00884838055322(21)70996 70953 (01)00884838055322(21)70953 70952 (01)00884838055322(21)70952 84470 (01)00884838055322(21)84470 84276 (01)00884838055322(21)84276 70685 N/A 84369 (01)00884838055322(21)84369 70405 N/A 70982 N/A 70915 N/A 84933 (01)00884838055322(21)84933 70230 N/A 70841 (01)00884838055322(21)70841 84206 (01)00884838055322(21)84206 84214 (01)00884838055322(21)84214 84308 (01)00884838055322(21)84308 84416 (01)00884838055322(21)84416 84482 (01)00884838055322(21)84482 84479 (01)00884838055322(21)84479 84558 (01)00884838055322(21)84558 84620 N/A 84656 (01)00884838055322(21)84656 84808 N/A 84809 (01)00884838055322(21)84809 84848 (01)00884838055322(21)84848 70356 N/A 70677 N/A 70358 N/A 70359 N/A 70057 N/A 70080 N/A 70087 N/A 70097 N/A 70157 N/A 70610 N/A 70693 N/A 70810 N/A 84002 N/A 84003 N/A 84074 N/A 84237 (01)00884838055322(21)84237 84239 (01)00884838055322(21)84239 84338 (01)00884838055322(21)84338 84339 (01)00884838055322(21)84339 84367 (01)00884838055322(21)84367 84483 (01)00884838055322(21)84483 84529 (01)00884838055322(21)84529 84767 (01)00884838055322(21)84767 84849 (01)00884838055322(21)84849 84913 (01)00884838055322(21)84913 84915 (01)00884838055322(21)84915 84969 (01)00884838055322(21)84969 87022 (01)00884838055322(21)87022 84960 (01)00884838055322(21)84960 87095 (01)00884838055322(21)87095 87087 (01)00884838055322(21)87087 87094 (01)00884838055322(21)87094 87086 (01)00884838055322(21)87086 87158 (01)00884838055322(21)87158 87163 (01)00884838055322(21)87163 87259 (01)00884838055322(21)87259 70058 N/A 70225 N/A 70426 N/A 70468 N/A 70791 N/A 70849 N/A 84037 N/A 84036 (01)00884838055322(21)84036 84380 (01)00884838055322(21)84380 84633 (01)00884838055322(21)84633 84616 (01)00884838055322(21)84616 84651 (01)00884838055322(21)84651 84828 (01)00884838055322(21)84828 84827 (01)00884838055322(21)84827 84868 (01)00884838055322(21)84868 87226 (01)00884838055322(21)87226 84575 (01)00884838055322(21)84575 87209 (01)00884838055322(21)87209 70044 N/A 70049 N/A 70060 N/A 70052 N/A 70051 N/A 70042 N/A 70094 N/A 70050 N/A 70076 N/A 70062 N/A 70095 N/A 70063 N/A 70124 N/A 70135 N/A 70190 N/A 70195 N/A 70156 N/A 70061 N/A 70200 (01)00884838055322(21)70200 70260 N/A 70298 N/A 70259 N/A 70328 N/A 70308 N/A 70331 N/A 70292 N/A 70403 N/A 70438 N/A 70442 N/A 70447 N/A 70445 N/A 70619 N/A 70606 N/A 70455 N/A 70473 N/A 70636 N/A 70635 N/A 70627 N/A 70616 N/A 70676 N/A 70621 N/A 70659 N/A 70614 N/A 70699 N/A 70698 N/A 70672 N/A 70700 N/A 70695 N/A 70661 N/A 70694 N/A 70443 N/A 70724 N/A 70650 N/A 70675 N/A 70719 N/A 70758 N/A 70701 N/A 70707 N/A 70727 N/A 70706 N/A 70743 N/A 70749 N/A 70783 N/A 70762 N/A 70690 N/A 70788 N/A 70674 N/A 70769 N/A 70752 N/A 70819 N/A 70715 N/A 70808 N/A 70793 N/A 70779 N/A 70729 N/A 70646 N/A 70898 N/A 70863 N/A 70771 N/A 70835 N/A 70875 N/A 70939 N/A 70801 N/A 70894 N/A 70903 N/A 70951 N/A 70904 N/A 70857 N/A 70972 N/A 70928 N/A 70874 N/A 70893 N/A 70892 N/A 70925 N/A 70983 N/A 70911 N/A 84013 N/A 70963 N/A 84012 (01)00884838055322(21)84012 70977 N/A 70949 N/A 84063 (01)00884838055322(21)84063 84043 (01)00884838055322(21)84043 84075 (01)00884838055322(21)84075 84049 (01)00884838055322(21)84049 84077 (01)00884838055322(21)84077 84134 (01)00884838055322(21)84134 84155 (01)00884838055322(21)84155 70897 (01)00884838055322(21)70897 84181 (01)00884838055322(21)84181 84174 (01)00884838055322(21)84174 84173 (01)00884838055322(21)84173 84157 (01)00884838055322(21)84157 84168 (01)00884838055322(21)84168 84186 (01)00884838055322(21)84186 84169 (01)00884838055322(21)84169 84189 (01)00884838055322(21)84189 84184 (01)00884838055322(21)84184 84170 (01)00884838055322(21)84170 84192 (01)00884838055322(21)84192 84196 (01)00884838055322(21)84196 84225 (01)00884838055322(21)84225 84240 (01)00884838055322(2

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Albania, Andorra, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan Palestine, State of Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam.

device · product 2 of 12

Ingenia 1.5T Evolution-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Model: 781315

Z-2412-2021
Recall number
Z-2412-2021
Initiated
August 11, 2021
Classification
Class II
Status
Completed
Recalling firm
Philips North America Llc
Quantity
42 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment

Code information

Model: 78135 Serial Number Unique Device Identifier (UDI#) 61019 (01)00884838099715 61028 (01)00884838099715 61001 (01)00884838099715 61004 (01)00884838099715 61023 (01)00884838099715 61008 (01)00884838099715 61026 (01)00884838099715 61034 (01)00884838099715 61046 (01)00884838099715 61025 (01)00884838099715 61035 (01)00884838099715 61042 (01)00884838099715 61040 (01)00884838099715 61041 (01)00884838099715(21)61041 61007 (01)00884838099715 61014 (01)00884838099715 61018 (01)00884838099715 61000 N/A 61003 (01)00884838099715 61002 N/A 61006 N/A 61009 N/A 61013 N/A 61017 (01)00884838099715(21)61017 61032 (01)00884838099715(21)61032 61015 N/A 61005 (01)00884838099715 61020 (01)00884838099715 61043 (01)00884838099715 61029 (01)00884838099715 61030 (01)00884838099715 61033 (01)00884838099715(21)61033 61052 (01)00884838099715(21)61052 61064 (01)00884838099715(21)61064 61027 (01)00884838099715 61016 (01)00884838099715 61022 (01)00884838099715 61044 (01)00884838099715 61050 (01)00884838099715 61047 (01)00884838099715(21)61047 61053 (01)00884838099715(21)61053 61049 (01)00884838099715(21)61049

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Albania, Andorra, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan Palestine, State of Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam.

device · product 3 of 12

Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Model: 781347

Z-2413-2021
Recall number
Z-2413-2021
Initiated
August 11, 2021
Classification
Class II
Status
Completed
Recalling firm
Philips North America Llc
Quantity
144 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment

Code information

Model: 78137 Serial Number Unique Device Identifier (UDI#) 81045 N/A 81075 (01)00884838068421(21)81075 81076 (01)00884838068421(21)81076 81077 (01)00884838068421(21)81077 81096 (01)00884838068421(21)81096 81124 (01)00884838068421(21)81124 81114 (01)00884838068421(21)81114 81126 (01)00884838068421(21)81126 81125 (01)00884838068421(21)81125 81144 (01)00884838068421(21)81144 81145 (01)00884838068421(21)81145 81159 (01)00884838068421(21)81159 81003 N/A 81111 (01)00884838068421(21)81111 81050 N/A 81051 (01)00884838068421(21)81051 81090 (01)00884838068421(21)81090 81021 N/A 81038 N/A 81185 (01)00884838068421(21)81185 81179 (01)00884838068421(21)81179 81005 N/A 81006 N/A 81011 N/A 81009 N/A 81019 N/A 81020 N/A 81016 N/A 81023 N/A 81017 N/A 81024 N/A 81014 N/A 81018 N/A 81004 N/A 81041 N/A 81057 (01)00884838068421(21)81057 81055 (01)00884838068421(21)81055 81037 (01)00884838068421(21)81037 81049 (01)00884838068421(21)81049 81060 (01)00884838068421(21)81060 81056 (01)00884838068421(21)81056 81064 (01)00884838068421(21)81064 81062 (01)00884838068421(21)81062 81070 (01)00884838068421(21)81070 81078 (01)00884838068421(21)81078 81073 (01)00884838068421(21)81073 81074 (01)00884838068421(21)81074 81112 (01)00884838068421(21)81112 81115 (01)00884838068421(21)81115 81122 (01)00884838068421(21)81122 81147 (01)00884838068421(21)81147 81146 (01)00884838068421(21)81146 81153 (01)00884838068421(21)81153 81156 (01)00884838068421(21)81156 81158 (01)00884838068421(21)81158 81093 (01)00884838068421(21)81093 81027 N/A 81035 N/A 81010 (01)00884838068421(21)81010 81063 (01)00884838068421(21)81063 81028 (01)00884838068421(21)81028 81030 (01)00884838068421(21)81030 81106 (01)00884838068421(21)81106 81052 N/A 81067 (01)00884838068421(21)81067 81105 (01)00884838068421(21)81105 81116 (01)00884838068421(21)81116 81013 N/A 81007 N/A 81008 N/A 81040 N/A 81031 (01)00884838068421(21)81031 81152 (01)00884838068421(21)81152 81044 N/A 81167 (01)00884838068421(21)81167 81170 (01)00884838068421(21)81170 81171 (01)00884838068421(21)81171 81047 (01)00884838068421(21)81047 81059 (01)00884838068421(21)81059 81108 (01)00884838068421(21)81108 81148 (01)00884838068421(21)81148 81133 (01)00884838068421(21)81133 81001 N/A 81086 (01)00884838068421(21)81086 81118 (01)00884838068421(21)81118 81139 (01)00884838068421(21)81139 81140 (01)00884838068421(21)81140 81138 (01)00884838068421(21)81138 81151 (01)00884838068421(21)81151 81175 N/A 81184 N/A 81079 (01)00884838068421(21)81079 81069 (01)00884838068421(21)81069 81061 (01)00884838068421(21)81061 81065 (01)00884838068421(21)81065 81098 (01)00884838068421(21)81098 81085 (01)00884838068421(21)81085 81092 (01)00884838068421(21)81092 81091 (01)00884838068421(21)81091 81032 N/A 81043 (01)00884838068421(21)81043 81026 N/A 81129 (01)00884838068421(21)81129 81131 (01)00884838068421(21)81131 81149 (01)00884838068421(21)81149 81155 (01)00884838068421(21)81155 81162 (01)00884838068421(21)81162 81172 (01)00884838068421(21)81172 81165 (01)00884838068421(21)81165 81180 (01)00884838068421(21)81180 81084 (01)00884838068421(21)81084 81087 (01)00884838068421(21)81087 81088 (01)00884838068421(21)81088 81095 (01)00884838068421(21)81095 81094 (01)00884838068421(21)81094 81100 (01)00884838068421(21)81100 81127 (01)00884838068421(21)81127 81132 (01)00884838068421(21)81132 81174 (01)00884838068421(21)81174 81039 N/A 81071 (01)00884838068421(21)81071 81157 (01)00884838068421(21)81157 81176 (01)00884838068421(21)81176 81117 (01)00884838068421(21)81117 81173 (01)00884838068421(21)81173 81025 N/A 81097 (01)00884838068421(21)81097 81154 (01)00884838068421(21)81154 81015 N/A 81029 N/A 81046 N/A 81033 N/A 81034 N/A 81048 N/A 81042 N/A 81058 (01)00884838068421(21)81058 81080 (01)00884838068421(21)81080 81072 (01)00884838068421(21)81072 81103 (01)00884838068421(21)81103 81113 (01)00884838068421(21)81113 81123 (01)00884838068421(21)81123 81128 (01)00884838068421(21)81128 81137 (01)00884838068421(21)81137 81178 (01)00884838068421(21)81178

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Albania, Andorra, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan Palestine, State of Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam.

device · product 4 of 12

Ingenia 1.5T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781261 781262

Z-2414-2021
Recall number
Z-2414-2021
Initiated
August 11, 2021
Classification
Class II
Status
Completed
Recalling firm
Philips North America Llc
Quantity
12 units, 137 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment

Code information

Model: 781261 Serial Number Unique Device Identifier (UDI#) 77008 77000 77004 77007 77003 77001 77002 77018 77016 77019 77010 77014 Model:781262 77131 (01)00884838068445(21)77131 77031 N/A 77046 N/A 77070 N/A 77124 (01)00884838068445(21)77124 77144 (01)00884838068445(21)77144 77172 (01)00884838068445(21)77172 77074 (01)00884838068445(21)77074 77058 N/A 77114 N/A 77127 (01)00884838068445(21)77127 77160 (01)00884838068445(21)77160 77159 (01)00884838068445(21)77159 77182 (01)00884838068445(21)77182 77180 (01)00884838068445(21)77180 77171 (01)00884838068445(21)77171 77179 (01)00884838068445(21)77179 77048 N/A 77040 N/A 77034 N/A 77039 N/A 77035 N/A 77092 N/A 77140 (01)00884838068445(21)77140 77177 (01)00884838068445(21)77177 77181 (01)00884838068445(21)77181 77178 (01)00884838068445(21)77178 77041 N/A 77103 N/A 77193 (01)00884838068445(21)77193 77203 (01)00884838068445(21)77203 77134 (01)00884838068445(21)77134 77047 N/A 77051 N/A 77050 N/A 77060 N/A 77194 (01)00884838068445(21)77194 77111 N/A 77119 (01)00884838068445(21)77119 77167 (01)00884838068445(21)77167 77183 (01)00884838068445(21)77183 77185 (01)00884838068445(21)77185 77187 (01)00884838068445(21)77187 77188 (01)00884838068445(21)77188 77198 (01)00884838068445(21)77198 77195 (01)00884838068445(21)77195 77196 (01)00884838068445(21)77196 77199 N/A 77202 N/A 77037 N/A 77057 N/A 77072 N/A 77075 N/A 77084 N/A 77085 N/A 77078 N/A 77086 N/A 77101 N/A 77110 (01)00884838068445(21)77110 77038 (01)00884838068445(21)77038 77157 (01)00884838068445(21)77157 77156 (01)00884838068445(21)77156 77056 N/A 77052 N/A 77054 N/A 77053 N/A 77055 N/A 77064 N/A 77065 N/A 77067 N/A 77066 N/A 77068 N/A 77069 N/A 77105 N/A 77126 (01)00884838068445(21)77126 77125 (01)00884838068445(21)77125 77137 (01)00884838068445(21)77137 77139 (01)00884838068445(21)77139 77136 (01)00884838068445(21)77136 77135 (01)00884838068445(21)77135 77138 (01)00884838068445(21)77138 77148 (01)00884838068445(21)77148 77141 (01)00884838068445(21)77141 77030 N/A 77033 N/A 77036 N/A 77042 N/A 77044 N/A 77043 N/A 77032 N/A 77049 N/A 77061 N/A 77059 N/A 77071 N/A 77090 N/A 77088 N/A 77093 N/A 77091 N/A 77087 N/A 77097 N/A 77083 N/A 77106 N/A 77112 N/A 77107 (01)00884838068445(21)77107 77115 N/A 77100 (01)00884838068445(21)77100 77118 (01)00884838068445(21)77118 77121 (01)00884838068445(21)77121 77129 (01)00884838068445(21)77129 77120 (01)00884838068445(21)77120 77128 (01)00884838068445(21)77128 77151 (01)00884838068445(21)77151 77143 (01)00884838068445(21)77143 77158 (01)00884838068445(21)77158 77162 (01)00884838068445(21)77162 77161 (01)00884838068445(21)77161 77155 (01)00884838068445(21)77155 77190 (01)00884838068445(21)77190 77191 (01)00884838068445(21)77191 77150 (01)00884838068445(21)77150 77081 N/A 77117 (01)00884838068445(21)77117 77123 (01)00884838068445(21)77123 77166 (01)00884838068445(21)77166 77045 N/A 77063 N/A 77109 N/A 77201 (01)00884838068445(21)77201 77113 N/A 77147 (01)00884838068445(21)77147 77122 (01)00884838068445(21)77122 77154 (01)00884838068445(21)77154 77169 (01)00884838068445(21)77169 77168 (01)00884838068445(21)77168 77130 (01)00884838068445(21)77130 77094 N/A 77062 N/A

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Albania, Andorra, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan Palestine, State of Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam.

device · product 5 of 12

SmartPath to dStream for 1.5T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781260

Z-2415-2021
Recall number
Z-2415-2021
Initiated
August 11, 2021
Classification
Class II
Status
Completed
Recalling firm
Philips North America Llc
Quantity
566 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment

Code information

Serial Number Unique Device Identifier (UDI#) 8750 N/A 32245 N/A 9013 N/A 8554 N/A 20211 N/A 18801 N/A 8178 N/A 10164 N/A 8752 N/A 10139 N/A 11076 N/A 8156 N/A 8646 N/A 22116 N/A 21175 N/A 8118 N/A 32443 N/A 32444 N/A 32445 N/A 18561 N/A 18761 N/A 30037 N/A 30146 N/A 21748 N/A 20003 N/A 21384 N/A 20116 N/A 20115 N/A 33220 N/A 18746 (01)00884838095076 8074 (01)00884838095076 18853 (01)00884838095076 21349 (01)00884838095076 18986 (01)00884838095076 18943 (01)00884838095076 18583 (01)00884838095076 22144 (01)00884838095076 22266 (01)00884838095076(21)22266 33045 (01)00884838095076(21)33045 32262 (01)00884838095076(21)32262 11100 (01)00884838095076(21)11100 5572 N/A 10236 N/A 12030 N/A 10183 N/A 72077 N/A 8985 N/A 21466 N/A 8240 N/A 32643 N/A 12084 N/A 8260 N/A 8942 N/A 21912 N/A 32180 N/A 21736 N/A 32059 (01)00884838095076 8917 N/A 10087 N/A 8713 N/A 10130 N/A 32621 N/A 18673 N/A 18701 N/A 30067 N/A 21775 (01)00884838095076 21679 N/A 32086 N/A 22220 N/A 8001 N/A 20070 N/A 10717 N/A 39103 N/A 5523 N/A 10511 N/A 10170 N/A 8642 N/A 21033 N/A 11030 N/A 10061 N/A 11031 N/A 8318 N/A 10174 N/A 18665 N/A 8611 N/A 8084 N/A 10191 N/A 8387 N/A 21932 N/A 8025 N/A 18644 N/A 5463 N/A 21142 N/A 8559 N/A 20057 N/A 11102 N/A 18631 N/A 8804 N/A 18565 N/A 5447 N/A 21015 N/A 10075 N/A 11062 N/A 30045 N/A 32176 N/A 8407 N/A 8512 N/A 8021 N/A 32752 N/A 21676 N/A 11001 N/A 18697 N/A 32710 N/A 32438 N/A 21171 N/A 39031 N/A 10033 N/A 5539 N/A 32636 N/A 21392 N/A 8129 N/A 8397 N/A 11108 N/A 11000 N/A 8704 N/A 13082 N/A 10179 N/A 8263 N/A 10523 N/A 32092 N/A 32113 N/A 32341 N/A 32334 N/A 8110 N/A 18957 N/A 8487 N/A 18938 N/A 32454 N/A 12082 N/A 9020 (01)00884838095076 9024 (01)00884838095076 8736 (01)00884838095076 8885 (01)00884838095076 22194 (01)00884838095076 21018 (01)00884838095076 21814 (01)00884838095076 5484 (01)00884838095076 10117 (01)00884838095076 8476 (01)00884838095076 30097 (01)00884838095076 8315 (01)00884838095076 32163 (01)00884838095076 32099 (01)00884838095076 8401 (01)00884838095076 21082 (01)00884838095076 21453 (01)00884838095076 18013 (01)00884838095076 18906 (01)00884838095076 32164 (01)00884838095076 8321 (01)00884838095076 8486 (01)00884838095076 10008 (01)00884838095076 18894 (01)00884838095076 32322 (01)00884838095076 8175 (01)00884838095076 32340 (01)00884838095076 39018 (01)00884838095076 5425 (01)00884838095076(21)5425 8096 (01)00884838095076(21)8096 8010 N/A 8179 N/A 39003 N/A 21003 N/A 8923 N/A 8087 N/A 8601 N/A 8659 N/A 18690 N/A 8215 N/A 32449 N/A 32127 N/A 32467 (01)00884838095076 8427 N/A 10528 (01)00884838095076 10900 N/A 21768 (01)00884838095076 8862 (01)00884838095076 21710 (01)00884838095076 8081 N/A 8485 N/A 8799 N/A 5490 N/A 5479 N/A 21294 N/A 8819 N/A 8967 N/A 8779 N/A 8746 N/A 8200 N/A 10716 N/A 12047 N/A 21477 N/A 8550 (01)00884838095076 21133 (01)00884838095076 21577 (01)00884838095076 32845 (01)00884838095076(21)32845 21050 N/A 21223 N/A 22154 N/A 21554 N/A 32754 N/A 32049 N/A 22070 N/A 72054 N/A 10079 N/A 20198 N/A 8895 N/A 21880 N/A 8884 N/A 21084 N/A 20151 N/A 20152 N/A 21804 N/A 8492 (01)00884838095076 32807 (01)00884838095076 5505 N/A 5499 N/A 8657 (01)00884838095076 32680 (01)00884838095076 32283 (01)00884838095076 10029 N/A 8054 N/A 8350 N/A 21087 N/A 21737 N/A 18940 N/A 32140 N/A 32361 N/A 21184 N/A 33126 N/A 21942 N/A 11072 N/A 21680 N/A 21691 N/A 33051 N/A 22103 N/A 32822 N/A 21694 N/A 18720 N/A 72081 N/A 21141 N/A 33023 (01)00884838095076 21247 (01)00884838095076 18575 (01)00884838095076 0 N/A 30132 (01)00884838095076(21)30132 18718 N/A 32285 (01)00884838095076(21)32285 21363 N/A 13011 N/A 20132 N/A 21032 N/A 22182 N/A 13052 N/A 9022 N/A 8119 N/A 18655 N/A 20111 N/A 32506 N/A 5466 N/A 21343 N/A 22299 N/A 32450 N/A 8786 N/A 8311 N/A 8395 N/A 9004 N/A 5546 N/A 5537 N/A 8712 N/A 8667 N/A 18101 N/A 10044 N/A 8478 N/A 10457 N/A 18511 N/A 10220 N/A 10554 N/A 0 N/A 11046 N/A 32264 N/A 32410 N/A 32492 N/A 18970 N/A 39037 N/A 8840 N/A 10185 N/A 13001 N/A 8365 N/A 72243 N/A 18509 N/A 33100 N/A 8641 N/A 18597 N/A 21623 N/A 18069 N/A 12036 N/A 8251 N/A 18035 N/A 22055 N/A 21011 N/A 32849 N/A 22296 N/A 32990 N/A 21551 N/A 11017 N/A 20164 N/A 8431 N/A 10552 N/A 8330 N/A 20196 N/A 21362 (01)00884838095076 21892 (01)00884838095076 20413 (01)00884838095076 72239 (01)00884838095076 22044 (01)00884838095076 8045 (01)00884838095076 21890 (01)00884838095076 21809 (01)00884838095076(21)21809 32478 (01)00884838095076(21)32478 8591 N/A 13032 N/A 22227 N/A 8012 N/A 8724 N/A 8949 N/A 13073 N/A 20288 N/A 20263 N/A 21482 N/A 5511 N/A 10208 N/A 8481 N/A 8555 N/A 10498 N/A 11042 N/A 8857 N/A 22098 N/A 13062 N/A 21278 N/A 21129 N/A 9007 N/A 11047 N/A 13029 N/A 18038 N/A 12114 N/A 8896 N/A 11091 N/A 13047 N/A 8057 N/A 12055 N/A 20302 N/A 8309 N/A 21560 N/A 21156 N/A 10906 N/A 10513 N/A 21697 N/A 20033 N/A 13046 N/A 10719 N/A 21759 N/A 20319 N/A 8831 N/A 10913 N/A 18060 N/A 10151 N/A 8060 N/A 21062 N/A 20002 N/A 18929 N/A 8531 N/A 11005 N/A 18107 N/A 20195 N/A 20011 N/A 8843 N/A 20237 N/A 21969 N/A 20278 N/A 21355 N/A 8305 N/A 18704 N/A 21583 N/A 8913 N/A 21222 N/A 20209 N/A 20187 N/A 21780 N/A 8094 N/A 8561 N/A 22013 N/A 8711 N/A 21987 N/A 12120 N/A 10007 N/A 21209 N/A 21182 N/A 21403 N/A 21640 N/A 8887 N/A 18524 N/A 21213 N/A 21519 N/A 21579 N/A 21448 (01)00884838095076 22184 (01)00884838095076 18017 (01)00884838095076 18954 (01)00884838095076 22157 (01)00884838095076 8517 (01)00884838095076 22248 (01)00884838095076 21089 (01)00884838095076 22123 (01)00884838095076 21249 (01)00884838095076 32258 (01)00884838095076(21)32258 32236 (01)00884838095076(21)32236 39009 (01)00884838095076(21)39009 20035 (01)00884838095076(21)20035 22175 (01)00884838095076(21)22175 21326 (01)00884838095076(21)21326 32132 (01)00884838095076(21)32132 10458 N/A 10544 N/A 10915 N/A 21253 N/A 22031 (01)00884838095076(21)22031 18808 N/A 13069 N/A 33352 (01)00884838095076 8091 N/A 18800 N/A 21067 N/A 21481 N/A 18610 N/A 18948 (01)00884838095076 33062 (01)00884838095076 22237 (01)00884838095076 8686 N/A 21023 N/A 8378 N/A 5563 N/A 18663 N/A 21019 N/A 8639 N/A 32742 N/A 20322 N/A 18699 (01)00884838095076 22347 (01)00884838095076 32119 (01)00884838095076(21)32119 8608 N/A 8783 N/A 21960 N/A 8086 N/A 21458 N/A 22189 N/A 21591 N/A 8292 N/A 10543 N/A 32573 (01)00884838095076 8566 N/A 32145 (01)00884838095076 10086 N/A 8983 N/A 18985 (01)00884838095076 21621 (01)00884838095076 22342 N/A 32391 N/A 8723 N/A 22301 N/A 10530 (01)00884838095076 10161 (01)00884838095076(21)10161 21498 N/A 8168 N/A 8451 N/A 18512 N/A 21929 N/A 22285 N/A 8616 N/A 8706 N/A 8687 N/A 32311 N/A 32513 N/A 20112 N/A 32094 N/A 12134 N/A 21888 N/A 32184 N/A 21438 N/A 22060 N/A 8092 N/A 32406 N/A 13018 N/A 8948 N/A 22127 N/A 32221 N/A 32218 N/A 8851 N/A 11085 N/A 12072 N/A 32147 N/A 32374 N/A 32405 N/A 22102 N/A 32296 N/A 22137 (01)00884838095076 22100 (01)00884838095076 8190 N/A 32142 N/A 10570 N/A 11018 N/A 12115 N/A 8392 N/A 22107 N/A 39024 N/A 21290 N/A 10077 N/A 10703 N/A 39005 N/A 8715 N/A 20071 N/A 8996 N/A 21540 N/A 18528 N/A 20226 N/A 8971 N/A 8578 N/A 12033 N/A 32174 N/A 8630 N/A 10196 N/A 21664 N/A 8560 N/A 18559 N/A 32131 N/A 18726 N/A 21108 N/A 8772 N/A 8835 N/A 18558 N/A 10154 N/A 21788 (01)00884838095076 8100 (01)00884838095076 5475 (01)00884838095076 9001 (01)00884838095076 12034 (01)00884838095076 10036 (01)00884838095076 10482 (01)00884838095076 8906 (01)00884838095076 8760 (01)00884838095076 8975 (01)00884838095076(21)8975 8354 N/A 9006 N/A 32200 N/A 8694 (01)00884838095076

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Albania, Andorra, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan Palestine, State of Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam.

device · product 6 of 12

Ingenia Ambition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781359

Z-2416-2021
Recall number
Z-2416-2021
Initiated
August 11, 2021
Classification
Class II
Status
Completed
Recalling firm
Philips North America Llc
Quantity
99 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment

Code information

Serial Number Unique Device Identifier (UDI#) 48026 (01)00884838090057(21)48026 48016 (01)00884838090057(21)48016 48053 (01)00884838090057(21)48053 48003 (01)00884838090057(21)48003 48136 (01)00884838090057(21)48136 48144 (01)00884838090057(21)48144 48020 (01)00884838090057(21)48020 48155 (01)00884838090057(21)48155 48191 (01)00884838090057(21)48191 48216 (01)00884838090057(21)48216 48124 (01)00884838090057(21)48124 48030 (01)00884838090057(21)48030 48011 (01)00884838090057(21)48011 48183 (01)00884838090057(21)48183 48186 (01)00884838090057(21)48186 48187 (01)00884838090057(21)48187 48234 (01)00884838090057(21)48234 48051 (01)00884838090057(21)48051 48000 (01)00884838090057(21)48000 48004 (01)00884838090057(21)48004 48009 (01)00884838090057(21)48009 48005 (01)00884838090057(21)48005 48019 (01)00884838090057(21)48019 48032 (01)00884838090057(21)48032 48132 (01)00884838090057(21)48132 48224 (01)00884838090057(21)48224 48223 (01)00884838090057(21)48223 48207 (01)00884838090057(21)48207 48015 (01)00884838090057(21)48015 48028 N/A 48154 N/A 48160 N/A 48134 N/A 48049 N/A 48031 N/A 48050 N/A 48131 N/A 48040 (01)00884838090057(21)48040 48039 (01)00884838090057(21)48039 48152 (01)00884838090057(21)48152 48173 (01)00884838090057(21)48173 48122 (01)00884838090057(21)48122 48022 (01)00884838090057(21)48022 48012 (01)00884838090057(21)48012 48014 (01)00884838090057(21)48014 48037 (01)00884838090057(21)48037 48036 (01)00884838090057(21)48036 48158 (01)00884838090057(21)48158 48127 (01)00884838090057(21)48127 48044 (01)00884838090057(21)48044 48184 (01)00884838090057(21)48184 48151 (01)00884838090057(21)48151 48174 (01)00884838090057(21)48174 48043 (01)00884838090057(21)48043 48046 (01)00884838090057(21)48046 48055 (01)00884838090057(21)48055 48047 (01)00884838090057(21)48047 48128 (01)00884838090057(21)48128 48129 (01)00884838090057(21)48129 48180 (01)00884838090057(21)48180 48192 (01)00884838090057(21)48192 48194 (01)00884838090057(21)48194 48153 (01)00884838090057(21)48153 48190 (01)00884838090057(21)48190 48226 (01)00884838090057(21)48226 48045 (01)00884838090057(21)48045 48033 N/A 48023 (01)00884838090057(21)48023 48181 (01)00884838090057(21)48181 48200 (01)00884838090057(21)48200 48199 (01)00884838090057(21)48199 48198 N/A 48001 (01)00884838090057(21)48001 48038 (01)00884838090057(21)48038 48167 (01)00884838090057(21)48167 48196 (01)00884838090057(21)48196 48034 (01)00884838090057(21)48034 48035 (01)00884838090057(21)48035 48172 (01)00884838090057(21)48172 48010 (01)00884838090057(21)48010 48027 N/A 48169 (01)00884838090057(21)48169 48182 (01)00884838090057(21)48182 48148 (01)00884838090057(21)48148 48188 (01)00884838090057(21)48188 48018 (01)00884838090057(21)48018 48017 (01)00884838090057(21)48017 48056 (01)00884838090057(21)48056 48112 (01)00884838090057(21)48112 48052 (01)00884838090057(21)48052 48130 (01)00884838090057(21)48130 48013 (01)00884838090057(21)48013 48162 (01)00884838090057(21)48162 48120 (01)00884838090057(21)48120 48171 (01)00884838090057(21)48171 48166 (01)00884838090057(21)48166 48179 (01)00884838090057(21)48179 48214 (01)00884838090057(21)48214 48133 (01)00884838090057(21)48133

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Albania, Andorra, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan Palestine, State of Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam.

device · product 7 of 12

Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377

Z-2417-2021
Recall number
Z-2417-2021
Initiated
August 11, 2021
Classification
Class II
Status
Completed
Recalling firm
Philips North America Llc
Quantity
964 units, 422 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment

Code information

Serial Number Unique Device Identifier (UDI#) Model: 781342 71352 N/A 71426 N/A 71977 (01)00884838055339(21)71977 85020 (01)00884838055339(21)85020 85106 (01)00884838055339(21)85106 71011 N/A 71152 N/A 71526 N/A 71433 (01)00884838055339(21)71433 71710 (01)00884838055339(21)71710 71817 (01)00884838055339(21)71817 71812 (01)00884838055339(21)71812 71403 (01)00884838055339(21)71403 71311 N/A 71345 N/A 71392 N/A 71395 N/A 71628 N/A 71723 (01)00884838055339(21)71723 85393 (01)00884838055339(21)85393 71042 N/A 71101 N/A 71168 N/A 71179 N/A 71178 N/A 71214 N/A 71252 N/A 71313 N/A 71342 N/A 71328 N/A 71309 N/A 71419 N/A 71453 N/A 71555 N/A 71557 N/A 71550 N/A 71551 N/A 71693 (01)00884838055339(21)71693 71674 (01)00884838055339(21)71674 71733 (01)00884838055339(21)71733 71859 (01)00884838055339(21)71859 71949 (01)00884838055339(21)71949 71993 (01)00884838055339(21)71993 71994 (01)00884838055339(21)71994 85045 (01)00884838055339(21)85045 85036 (01)00884838055339(21)85036 85155 (01)00884838055339(21)85155 85115 (01)00884838055339(21)85115 71602 (01)00884838055339(21)71602 71216 N/A 71651 N/A 71950 (01)00884838055339(21)71950 85208 (01)00884838055339(21)85208 71163 N/A 71408 N/A 71499 N/A 71493 N/A 71541 N/A 71580 N/A 71668 (01)00884838055339(21)71668 71729 (01)00884838055339(21)71729 71771 (01)00884838055339(21)71771 71726 (01)00884838055339(21)71726 71260 N/A 71324 N/A 71276 N/A 71800 (01)00884838055339(21)71800 71068 N/A 71081 N/A 71300 N/A 71481 N/A 71482 N/A 71006 N/A 71018 N/A 71044 N/A 71072 N/A 71040 N/A 71189 N/A 71198 N/A 71197 N/A 71224 N/A 71332 N/A 71320 N/A 71366 N/A 71434 N/A 71442 N/A 71384 N/A 71448 N/A 71487 N/A 71597 N/A 71496 N/A 71623 (01)00884838055339(21)71623 71486 (01)00884838055339(21)71486 71704 (01)00884838055339(21)71704 71749 (01)00884838055339(21)71749 71703 (01)00884838055339(21)71703 71752 (01)00884838055339(21)71752 71706 (01)00884838055339(21)71706 71831 (01)00884838055339(21)71831 71644 (01)00884838055339(21)71644 71645 (01)00884838055339(21)71645 71737 (01)00884838055339(21)71737 71871 (01)00884838055339(21)71871 85081 (01)00884838055339(21)85081 85143 N/A 85142 (01)00884838055339(21)85142 85114 (01)00884838055339(21)85114 71339 N/A 71730 (01)00884838055339(21)71730 71452 N/A 71470 N/A 71468 N/A 71465 N/A 71471 N/A 71492 N/A 71485 N/A 71467 N/A 71480 N/A 71464 N/A 71509 N/A 71520 N/A 71479 N/A 71548 N/A 71514 N/A 71517 N/A 71472 N/A 71505 N/A 71516 N/A 71596 N/A 71497 N/A 71554 N/A 71511 N/A 71588 N/A 71553 N/A 71560 N/A 71601 N/A 71626 N/A 71594 N/A 71614 N/A 71544 (01)00884838055339(21)71544 71624 N/A 71637 N/A 71519 N/A 71621 N/A 71629 N/A 71642 N/A 71473 N/A 71506 N/A 71605 N/A 71653 (01)00884838055339(21)71653 71654 (01)00884838055339(21)71654 71633 (01)00884838055339(21)71633 71692 (01)00884838055339(21)71692 71660 (01)00884838055339(21)71660 71709 (01)00884838055339(21)71709 71708 (01)00884838055339(21)71708 71698 (01)00884838055339(21)71698 71622 (01)00884838055339(21)71622 71699 (01)00884838055339(21)71699 71567 (01)00884838055339(21)71567 71734 (01)00884838055339(21)71734 71755 (01)00884838055339(21)71755 71738 (01)00884838055339(21)71738 71702 (01)00884838055339(21)71702 71765 (01)00884838055339(21)71765 71713 (01)00884838055339(21)71713 71695 (01)00884838055339(21)71695 71784 (01)00884838055339(21)71784 71559 (01)00884838055339(21)71559 71779 (01)00884838055339(21)71779 71788 (01)00884838055339(21)71788 71783 (01)00884838055339(21)71783 71804 (01)00884838055339(21)71804 71818 (01)00884838055339(21)71818 71690 (01)00884838055339(21)71690 71821 (01)00884838055339(21)71821 71814 (01)00884838055339(21)71814 71839 (01)00884838055339(21)71839 71786 (01)00884838055339(21)71786 71866 (01)00884838055339(21)71866 71775 (01)00884838055339(21)71775 71819 (01)00884838055339(21)71819 71856 (01)00884838055339(21)71856 71687 (01)00884838055339(21)71687 71807 (01)00884838055339(21)71807 71855 (01)00884838055339(21)71855 71744 (01)00884838055339(21)71744 71714 (01)00884838055339(21)71714 71875 (01)00884838055339(21)71875 71894 (01)00884838055339(21)71894 71716 (01)00884838055339(21)71716 71707 (01)00884838055339(21)71707 71861 (01)00884838055339(21)71861 71955 (01)00884838055339(21)71955 71820 (01)00884838055339(21)71820 71872 (01)00884838055339(21)71872 71876 (01)00884838055339(21)71876 71928 (01)00884838055339(21)71928 71899 (01)00884838055339(21)71899 71987 (01)00884838055339(21)71987 71917 (01)00884838055339(21)71917 71898 (01)00884838055339(21)71898 71952 (01)00884838055339(21)71952 71935 (01)00884838055339(21)71935 71973 (01)00884838055339(21)71973 71930 (01)00884838055339(21)71930 71782 (01)00884838055339(21)71782 71945 (01)00884838055339(21)71945 85002 (01)00884838055339(21)85002 71840 (01)00884838055339(21)71840 71976 (01)00884838055339(21)71976 71656 (01)00884838055339(21)71656 71868 (01)00884838055339(21)71868 85005 (01)00884838055339(21)85005 71908 (01)00884838055339(21)71908 71745 (01)00884838055339(21)71745 71999 (01)00884838055339(21)71999 71998 (01)00884838055339(21)71998 85000 (01)00884838055339(21)85000 71610 (01)00884838055339(21)71610 71913 (01)00884838055339(21)71913 71887 (01)00884838055339(21)71887 85003 (01)00884838055339(21)85003 71742 (01)00884838055339(21)71742 71951 (01)00884838055339(21)71951 85026 (01)00884838055339(21)85026 85010 (01)00884838055339(21)85010 71988 (01)00884838055339(21)71988 85034 (01)00884838055339(21)85034 71946 (01)00884838055339(21)71946 71958 (01)00884838055339(21)71958 85079 (01)00884838055339(21)85079 71944 (01)00884838055339(21)71944 85097 (01)00884838055339(21)85097 85044 (01)00884838055339(21)85044 85061 (01)00884838055339(21)85061 85047 (01)00884838055339(21)85047 85049 (01)00884838055339(21)85049 71685 (01)00884838055339(21)71685 85089 (01)00884838055339(21)85089 85048 (01)00884838055339(21)85048 85024 (01)00884838055339(21)85024 71909 (01)00884838055339(21)71909 85105 (01)00884838055339(21)85105 85082 (01)00884838055339(21)85082 85095 (01)00884838055339(21)85095 85112 N/A 85096 (01)00884838055339(21)85096 71877 (01)00884838055339(21)71877 85028 (01)00884838055339(21)85028 85080 (01)00884838055339(21)85080 85099 (01)00884838055339(21)85099 85056 (01)00884838055339(21)85056 85146 (01)00884838055339(21)85146 85016 (01)00884838055339(21)85016 85111 (01)00884838055339(21)85111 85075 (01)00884838055339(21)85075 85042 (01)00884838055339(21)85042 71997 (01)00884838055339(21)71997 85073 (01)00884838055339(21)85073 85132 (01)00884838055339(21)85132 85169 (01)00884838055339(21)85169 85162 (01)00884838055339(21)85162 85153 (01)00884838055339(21)85153 85168 (01)00884838055339(21)85168 85037 (01)00884838055339(21)85037 85160 (01)00884838055339(21)85160 85141 (01)00884838055339(21)85141 71922 (01)00884838055339(21)71922 85165 (01)00884838055339(21)85165 85171 (01)00884838055339(21)85171 85157 (01)00884838055339(21)85157 85070 (01)00884838055339(21)85070 85170 N/A 85174 (01)00884838055339(21)85174 85184 (01)00884838055339(21)85184 85050 (01)00884838055339(21)85050 85177 (01)00884838055339(21)85177 85186 (01)00884838055339(21)85186 85098 (01)00884838055339(21)85098 85172 (01)00884838055339(21)85172 85192 (01)00884838055339(21)85192 85197 (01)00884838055339(21)85197 85152 (01)00884838055339(21)85152 85204 (01)00884838055339(21)85204 85226 (01)00884838055339(21)85226 85195 (01)00884838055339(21)85195 85200 (01)00884838055339(21)85200 85215 (01)00884838055339(21)85215 85188 (01)00884838055339(21)85188 85231 (01)00884838055339(21)85231 85237 (01)00884838055339(21)85237 85238 (01)00884838055339(21)85238 85233 (01)00884838055339(21)85233 85243 (01)00884838055339(21)85243 85199 (01)00884838055339(21)85199 71957 (01)00884838055339(21)71957 85234 (01)00884838055339(21)85234 85218 (01)00884838055339(21)85218 85178 N/A 85251 (01)00884838055339(21)85251 85258 (01)00884838055339(21)85258 85219 (01)00884838055339(21)85219 85247 (01)00884838055339(21)85247 85277 (01)00884838055339(21)85277 85230 (01)00884838055339(21)85230 85282 (01)00884838055339(21)85282 85242 (01)00884838055339(21)85242 85272 (01)00884838055339(21)85272 85065 (01)00884838055339(21)85065 85305 (01)00884838055339(21)85305 85198 (01)00884838055339(21)85198 85290 (01)00884838055339(21)85290 85291 (01)00884838055339(21)85291 85310 (01)00884838055339(21)85310 85284 (01)00884838055339(21)85284 85311 (01)00884838055339(21)85311 85313 (01)00884838055339(21)85313 85220 (01)00884838055339(21)85220 85268 (01)00884838055339(21)85268 85300 (01)00884838055339(21)85300 85127 (01)00884838055339(21)85127 85294 (01)00884838055339(21)85294 85285 (01)00884838055339(21)85285 85309 (01)00884838055339(21)85309 85280 (01)00884838055339(21)85280 85288 (01)00884838055339(21)85288 85314 (01)00884838055339(21)85314 85270 (01)00884838055339(21)85270 85325 (01)00884838055339(21)85325 85323 (01)00884838055339(21)85323 85339 (01)00884838055339(21)85339 85283 (01)00884838055339(21)85283 85333 (01)00884838055339(21)85333 85334 (01)00884838055339(21)85334 85303 (01)00884838055339(21)85303 85269 (01)00884838055339(21)85269 85345 (01)00884838055339(21)85345 85351 (01)00884838055339(21)85351 85356 (01)00884838055339(21)85356 85349 (01)00884838055339(21)85349 85350 (01)00884838055339(21)85350 85354 (01)00884838055339(21)85354 85382 (01)00884838055339(21)85382 85362 (01)00884838055339(21)85362 85355 (01)00884838055339(21)85355 85332 (01)00884838055339(21)85332 85336 (01)00884838055339(21)85336 85371 (01)00884838055339(21)85371 85375 (01)00884838055339(21)85375 85380 (01)00884838055339(21)85380 85384 (01)00884838055339(21)85384 85370 (01)00884838055339(21)85370 85389 (01)00884838055339(21)85389 85385 (01)00884838055339(21)85385 85357 (01)00884838055339(21)85357 85335 (01)00884838055339(21)85335 85386 (01)00884838055339(21)85386 85387 (01)00884838055339(21)85387 85398 (01)00884838055339(21)85398 85383 (01)00884838055339(21)85383 85364 (01)00884838055339(21)85364 85390 (01)00884838055339(21)85390 85397 (01)00884838055339(21)85397 85406 (01)00884838055339(21)85406 0 N/A 85402 (01)00884838055339(21)85402 85418 (01)00884838055339(21)85418 85361 (01)00884838055339(21)85361 71609 N/A 71631 N/A 71834 N/A 71918 (01)00884838055339(21)71918 71372 N/A 71649 N/A 71581 (01)00884838055339(21)71581 71582 (01)00884838055339(21)71582 71748 (01)00884838055339(21)71748 71373 N/A 71405 N/A 71406 N/A 71979 (01)00884838055339(21)71979 85265 (01)00884838055339(21)85265 71020 N/A 71025 N/A 71019 N/A 71003 N/A 71084 N/A 71023 N/A 71173 N/A 71192 N/A 71283 N/A 71298 N/A 71337 N/A 71315 N/A 71363 N/A 71288 N/A 71278 N/A 71359 N/A 71440 N/A 71396 N/A 71501 N/A 71370 N/A 71390 N/A 71400 N/A 71603 N/A 71521 N/A 71607 N/A 71590 (01)00884838055339(21)71590 71576 (01)00884838055339(21)71576 71725 (01)00884838055339(21)71725 71773 (01)00884838055339(21)71773 71791 (01)00884838055339(21)71791 71774 (01)00884838055339(21)71774 71874 (01)00884838055339(21)71874 71838 (01)00884838055339(21)71838 71751 (01)00884838055339(21)71751 85031 (01)00884838055339(21)85031 85025 (01)00884838055339(21)85025 85180 (01)00884838055339(21)85180 85161 (01)00884838055339(21)85161 85341 (01)00884838055339(21)85341 85342 (01)00884838055339(21)85342 85319 (01)00884838055339(21)85319 85391 (01)00884838055339(21)85391 71047 N/A 71678 (01)00884838055339(21)71678 71662 (01)00884838055339(21)71662 71891 (01)00884838055339(21)71891 85189 (01)00884838055339(21)85189 71474 N/A 71267 N/A 71402 N/A 71457 N/A 71353 (01)00884838055339(21)71353 71412 N/A 71443 N/A 71650 N/A 71604 (01)00884838055339(21)71604 71689 (01)00884838055339(21)71689 71823 N/A 71896 (01)00884838055339(21)71896 71895 (01)00884838055339(21)71895 71954 (01)00884838055339(21)71954 85059 (01)00884838055339(21)85059 85085 (01)00884838055339(21)85085 85092 (01)00884838055339(21)85092 85087 (01)00884838055339(21)85087 85340 (01)00884838055339(21)85340 71231 N/A 71338 N/A 71418 N/A 71924 (01)00884838055339(21)71924 71051 N/A 71050 N/A 71266 N/A 71439 N/A 71595 N/A 71612 (01)00884838055339(21)71612 71613 (01)00884838055339(21)71613 71815 (01)00884838055339(21)71815 71799 (01)00884838055339(21)71799 71991 (01)00884838055339(21)71991 85011 (01)00884838055339(21)85011 85202 (01)00884838055339(21)85202 85306 N/A 71008 N/A 71215 N/A 71318 N/A 71308 N/A 71354 N/A 71287 N/A 71285 N/A 71459 N/A 71490 N/A 71534 N/A 71754 (01)00884838055339(21)71754 71806 (01)00884838055339(21)71806 85015 (01)00884838055339(21)85015 71962 (01)00884838055339(21)71962 71964 (01)00884838055339(21)71964 71963 (01)00884838055339(21)71963 85101 (01)00884838055339(21)85101 71437 N/A 71504 N/A 71394 N/A 71910 (01)00884838055339(21)71910 85063 (01)00884838055339(21)85063 85183 (01)00884838055339(21)85183 85206 (01)00884838055339(21)85206 85216 (01)00884838055339(21)85216 71334 N/A 71409 N/A 71476 N/A 85023 (01)00884838055339(21)85023 71367 N/A 71545 N/A 71461 N/A 85241 (01)00884838055339(21)85241 85302 (01)00884838055339(21)85302 85348 (01)00884838055339(21)85348 85372 N/A 71423 N/A 71184 N/A 71462 N/A 71619 (01)00884838055339(21)71619 71620 (01)00884838055339(21)71620 71061 N/A 71087 N/A 71106 N/A 71165 N/A 71162 N/A 71181 N/A 71351 N/A 71280 N/A 71389 N/A 71393 N/A 71410 N/A 71428 N/A 71422 N/A 71460 N/A 71477 N/A 71512 N/A 71349 N/A 71357 (01)00884838055339(21)71357 71643 N/A 71691 (01)00884838055339(21)71691 71518 (01)00884838055339(21)71518 71743 N/A 71717 (01)00884838055339(21)71717 71763 (01)00884838055339(21)71763 71762 (01)00884838055339(21)71762 71677 (01)00884838055339(21)71677 71854 (01)00884838055339(21)71854 71842 (01)00884838055339(21)71842 71900 (01)00884838055339(21)71900 71967 (01)00884838055339(21)71967 85122 (01)00884838055339(21)85122 85149 (01)00884838055339(21)85149 85190 (01)00884838055339(21)85190 85147 (01)00884838055339(21)85147 85203 (01)00884838055339(21)85203 71966 N/A 85140 (01)00884838055339(21)85140 85318 (01)00884838055339(21)85318 85210 N/A 85347 N/A 71164 N/A 71177 N/A 71326 N/A 71424 N/A 71639 (01)00884838055339(21)71639 71688 (01)00884838055339(21)71688 71759 (01)00884838055339(21)71759 71681 (01)00884838055339(21)71681 71758 (01)00884838055339(21)71758 71863 (01)00884838055339(21)71863 71892 (01)00884838055339(21)71892 71926 (01)00884838055339(21)71926 85145 (01)00884838055339(21)85145 85057 (01)00884838055339(21)85057 85245 (01)00884838055339(21)85245 85246 (01)00884838055339(21)85246 71086 N/A 71343 N/A 71679 (01)00884838055339(21)71679 71671 (01)00884838055339(21)71671 71001 N/A 71014 N/A 71004 N/A 71002 N/A 71007 N/A 71039 N/A 71012 N/A 71013 N/A 71056 N/A 71035 N/A 71037 N/A 71070 N/A 71089 N/A 71154 N/A 71095 N/A 71093 N/A 71174 N/A 71175 N/A 71155 N/A 71183 N/A 71211 N/A 71210 N/A 71268 N/A 71269 N/A 71271 N/A 71282 N/A 71301 N/A 71325 N/A 71341 N/A 71347 N/A 71361 N/A 71385 N/A 71413 N/A 71416 N/A 71401 N/A 71411 N/A 71441 N/A 71450 N/A 71429 N/A 71425 N/A 71427 N/A 71438 N/A 71491 N/A 71489 N/A 71498 N/A 71500 N/A 71589 N/A 71463 N/A 71577 N/A 71562 N/A 71571 N/A 71558 N/A 71587 N/A 71527 (01)00884838055339(21)71527 71592 N/A 71673 (01)00884838055339(21)71673 71652 (01)00884838055339(21)71652 71682 (01)00884838055339(21)71682 71635 (01)00884838055339(21)71635 71670 (01)00884838055339(21)71670 71659 (01)00884838055339(21)71659 71655 (01)00884838055339(21)71655 71686 (01)00884838055339(21)71686 71684 (01)00884838055339(21)71684 71676 (01)00884838055339(21)71676 71772 (01)00884838055339(21)71772 71778 (01)00884838055339(21)71778 71801 (01)00884838055339(21)71801 71802 (01)00884838055339(21)71802 71766 (01)00884838055339(21)71766 71767 (01)00884838055339(21)71767 71780 (01)00884838055339(21)71780 71816 (01)00884838055339(21)71816 71760 (01)00884838055339(21)71760 71841 (01)00884838055339(21)71841 71849 (01)00884838055339(21)71849 71844 (01)00884838055339(21)71844 71882 (01)00884838055339(21)71882 71869 (01)00884838055339(21)71869 71851 (01)00884838055339(21)71851 71879 (01)00884838055339(21)71879 71878 (01)00884838055339(21)71878 71880 (01)00884838055339(21)71880 71694 (01)00884838055339(21)71694 71862 (01)00884838055339(21)71862 71850 (01)00884838055339(21)71850 71853 (01)00884838055339(21)71853 71897 (01)00884838055339(21)71897 71813 (01)00884838055339(21)71813 71885 (01)00884838055339(21)71885 71825 (01)00884838055339(21)71825 71864 (01)00884838055339(21)71864 71881 (01)00884838055339(21)71881 71921 (01)00884838055339(21)71921 71923 (01)00884838055339(21)71923 71972 (01)00884838055339(21)71972 71995 (01)00884838055339(21)71995 71992 (01)00884838055339(21)71992 85076 N/A 85064 (01)00884838055339(21)85064 85022 (01)00884838055339(21)85022 85074 (01)00884838055339(21)85074 85078 (01)00884838055339(21)85078 85038 (01)00884838055339(21)85038 85083 (01)00884838055339(21)85083 85068 (01)00884838055339(21)85068 85069 (01)00884838055339(21)85069 85124 (01)00884838055339(21)85124 85151 (01)00884838055339(21)85151 85121 (01)00884838055339(21)85121 85150 (01)00884838055339(21)85150 85217 (01)00884838055339(21)85217 85381 (01)00884838055339(21)85381 85400 (01)00884838055339(21)85400 71228 N/A 71107 N/A 85126 (01)00884838055339(21)85126 85166 (01)00884838055339(21)85166 71058 N/A 71078 N/A 71088 N/A 71176 N/A 71263 N/A 71299 N/A 71303 N/A 71321 N/A 71387 N/A 71307 N/A 71420 N/A 71475 N/A 71574 N/A 71640 N/A 71575 (01)00884838055339(21)71575 71658 (01)00884838055339(21)71658 71697 (01)00884838055339(21)71697 71625 (01)00884838055339(21)71625 71740 (01)00884838055339(21)71740 71757 (01)00884838055339(21)71757 71852 (01)00884838055339(21)71852 71984 (01)00884838055339(21)71984 85032 (01)00884838055339(21)85032 85102 (01)00884838055339(21)85102 85187 (01)00884838055339(21)85187 85181 (01)00884838055339(21)85181 85312 (01)00884838055339(21)85312 85330 (01)00884838055339(21)85330 71811 (01)00884838055339(21)71811 71172 N/A 71195 N/A 71790 (01)00884838055339(21)71790 71996 (01)00884838055339(21)71996 85004 (01)00884838055339(21)85004 71948 (01)00884838055339(21)71948 85046 (01)00884838055339(21)85046 85136 (01)00884838055339(21)85136 85223 (01)00884838055339(21)85223 85317 (01)00884838055339(21)85317 71600 N/A 71848 (01)00884838055339(21)71848 85109 (01)00884838055339(21)85109 85253 (01)00884838055339(21)85253 85301 (01)00884838055339(21)85301 71170 N/A 71153 N/A 71296 N/A 71356 N/A 71781 (01)00884838055339(21)71781 85213 (01)00884838055339(21)85213 71159 N/A 85021 (01)00884838055339(21)85021 71364 N/A 71380 N/A 71563 N/A 71953 (01)00884838055339(21)71953 71956 (01)00884838055339(21)71956 85232 (01)00884838055339(21)85232 85304 (01)00884838055339(21)85304 71166 N/A 71279 N/A 71290 N/A 71335 N/A 71375 N/A 71297 N/A 71608 N/A 71630 (01)00884838055339(21)71630 71715 N/A 71889 (01)00884838055339(21)71889 71919 N/A 85148 (01)00884838055339(21)85148 85367 (01)00884838055339(21)85367 71060 N/A 71611 (01)00884838055339(21)71611 71208 N/A 71097 N/A 71722 (01)00884838055339(21)71722 71026 N/A 71157 N/A 71381 N/A 71374 N/A 71647 N/A 71302 N/A 85366 (01)00884838055339(21)85366 71150 N/A 71188 N/A 71188 N/A 71360 N/A 71634 N/A 71665 (01)00884838055339(21)71665 71884 (01)00884838055339(21)71884 71225 N/A 71262 N/A 71348 N/A 71641 N/A 71510 (01)00884838055339(21)71510 71746 (01)00884838055339(21)71746 71753 (01)00884838055339(21)71753 85018 (01)00884838055339(21)85018 71648 N/A 71414 N/A 85236 (01)00884838055339(21)85236 85260 (01)00884838055339(21)85260 85368 (01)00884838055339(21)85368 85091 (01)00884838055339(21)85091 71220 N/A 71227 N/A 71350 N/A 71272 N/A 71451 N/A 71700 (01)00884838055339(21)71700 71522 (01)00884838055339(21)71522 71920 (01)00884838055339(21)71920 85012 (01)00884838055339(21)85012 85054 (01)00884838055339(21)85054 85316 (01)00884838055339(21)85316 85388 (01)00884838055339(21)85388 85414 (01)00884838055339(21)85414 71077 N/A 71365 N/A 71398 N/A 71204 N/A 71340 N/A 71305 N/A 71362 N/A 71445 N/A 71446 N/A 71508 N/A 71565 (01)00884838055339(21)71565 71564 (01)00884838055339(21)71564 71616 (01)00884838055339(21)71616 71615 (01)00884838055339(21)71615 71566 (01)00884838055339(21)71566 71925 (01)00884838055339(21)71925 71478 N/A 71618 N/A 71826 (01)00884838055339(21)71826 71669 (01)00884838055339(21)71669 71764 (01)00884838055339(21)71764 71833 (01)00884838055339(21)71833 71867 (01)00884838055339(21)71867 71017 N/A 71274 N/A 71291 N/A 71304 N/A 71368 N/A 71371 N/A 71484 N/A 71711 (01)00884838055339(21)71711 71756 (01)00884838055339(21)71756 71822 (01)00884838055339(21)71822 71860 (01)00884838055339(21)71860 71911 (01)00884838055339(21)71911 71936 (01)00884838055339(21)71936 71931 (01)00884838055339(21)71931 85125 (01)00884838055339(21)85125 85185 (01)00884838055339(21)85185 85123 (01)00884838055339(21)85123 85193 (01)00884838055339(21)85193 71333 N/A 71377 N/A 71386 N/A 71524 N/A 71789 (01)00884838055339(21)71789 71785 (01)00884838055339(21)71785 71986 (01)00884838055339(21)71986 85019 (01)00884838055339(21)85019 85209 (01)00884838055339(21)85209 85295 (01)00884838055339(21)85295 85322 (01)00884838055339(21)85322 71156 N/A 71314 N/A 71344 N/A 71323 N/A 71583 N/A 71808 (01)00884838055339(21)71808 71916 N/A 71038 N/A 71010 N/A 71027 N/A 71062 N/A 71029 N/A 71031 N/A 71022 N/A 71071 N/A 71016 N/A 71065 N/A 71073 N/A 71045 N/A 71064 N/A 71074 N/A 71185 N/A 71187 N/A 71194 N/A 71191 N/A 71193 N/A 71203 N/A 71200 N/A 71190 N/A 71213 N/A 71275 N/A 71319 N/A 71322 N/A 71277 N/A 71312 N/A 71329 N/A 71327 N/A 71331 N/A 71317 N/A 71336 N/A 71286 N/A 71378 N/A 71346 N/A 71358 N/A 71379 N/A 71376 N/A 71355 N/A 71388 N/A 71382 N/A 71444 N/A 71407 N/A 71449 N/A 71369 N/A 71495 N/A 71415 N/A 71483 N/A 71399 N/A 71532 N/A 71528 N/A 71529 N/A 71556 N/A 71569 N/A 71456 N/A 71513 N/A 71397 N/A 71570 N/A 71599 (01)00884838055339(21)71599 71584 N/A 71667 (01)00884838055339(21)71667 71675 (01)00884838055339(21)71675 71646 (01)00884838055339(21)71646 71739 (01)00884838055339(21)71739 71732 (01)00884838055339(21)71732 71721 (01)00884838055339(21)71721 71680 (01)00884838055339(21)71680 71683 (01)00884838055339(21)71683 71796 (01)00884838055339(21)71796 71805 (01)00884838055339(21)71805 71827 (01)00884838055339(21)71827 71810 (01)00884838055339(21)71810 71735 (01)00884838055339(21)71735 71836 (01)00884838055339(21)71836 71828 (01)00884838055339(21)71828 71858 (01)00884838055339(21)71858 71893 (01)00884838055339(21)71893 71750 (01)00884838055339(21)71750 71914 (01)00884838055339(21)71914 71829 (01)00884838055339(21)71829 71959 (01)00884838055339(21)71959 71907 (01)00884838055339(21)71907 71960 (01)00884838055339(21)71960 71982 (01)00884838055339(21)71982 85006 (01)00884838055339(21)85006 71971 (01)00884838055339(21)71971 85067 (01)00884838055339(21)85067 85094 (01)00884838055339(21)85094 85066 (01)00884838055339(21)85066 85154 (01)00884838055339(21)85154 85191 (01)00884838055339(21)85191 85221 (01)00884838055339(21)85221 85201 (01)00884838055339(21)85201 85279 (01)00884838055339(21)85279 85278 (01)00884838055339(21)85278 85275 (01)00884838055339(21)85275 85394 (01)00884838055339(21)85394 71436 N/A 85222 (01)00884838055339(21)85222 71161 N/A 71270 N/A Model: 781377 UDI N/A 42204 42190 42175 42154 42186 42246 42346 42354 42088 42153 42125 42026 42221 42231 42224 42291 42283 42167 42339 42319 42393 42387 42439 42441 42466 42002 42171 42147 42277 42305 42243 42198 42183 42182 42206 42213 42448 42215 42012 42009 42007 42011 42008 42010 42085 42079 42065 42164 42134 42165 42037 42132 42320 42176 42318 42230 42303 42350 42388 42332 42351 42399 42338 42419 42251 42326 42343 42362 42367 36 42380 42398 42436 42435 42444 42423 42446 42445 42453 42458 42459 42452 42454 42456 42463 42464 42437 42457 42469 42499 42490 42494 42492 42500 42495 42507 42496 42504 42508 42506 42510 42525 42528 42503 42547 42512 42548 42543 42522 42530 42556 42505 42545 42546 42549 42554 42555 42558 42553 42560 42502 42557 42491 42559 42561 42565 42552 42563 42520 42570 42531 42280 42493 42042 42239 42005 42013 42021 42030 42025 42073 42028 42027 42061 42029 42107 42081 42144 42145 42138 42130 42141 42202 42090 42082 42216 42143 42308 42292 42279 42363 42315 42369 42329 42313 42384 42178 42211 42321 42041 42197 42015 42092 42232 42265 42055 42114 42044 42220 42223 42358 42413 42323 42089 42086 42272 42136 42137 42072 42110 42191 42192 42195 42184 42225 42218 42285 42364 42407 42440 42426 42172 42284 42199 42275 42287 42062 42122 42014 42023 42048 42024 42047 42056 42075 42103 42054 42077 42070 42094 42124 42095 42128 42121 42093 42074 42162 42133 42078 42161 42179 42205 42112 42219 42203 42233 42222 42210 42249 42253 42261 42194 42257 42278 42288 42237 42245 42262 42276 42263 42314 42115 42260 42282 42252 42254 42289 42331 42309 42301 42345 42250 42299 42337 42333 42347 42361 42375 42392 42378 42404 42381 42385 42300 42330 42396 42349 42383 42425 42412 42409 42424 42421 42432 42422 42420 42442 42360 42428 42087 42120 42170 42201 42267 42386 42401 42415 42449 42450 42069 42294 42390 42451 42017 42228 42209 42151 42135 42271 42408 42217 42148 42402 42234 42235 42236 42353 42244 42455 42018 42105 42306 42256 42340 42355 42113 42097 42058 42264 42131 42348 42273 42001 42003 42006 42019 42040 42034 42033 42038 42036 42046 42031 42053 42032 42068 42052 42049 42100 42035 42104 42116 42045 42076 42096 42050 42102 42123 42152 42083 42109 42067 42101 42146 42117 42059 42111 42173 42163 42119 42099 42126 42127 42177 42180 42159 42160 42158 42150 42185 42189 42066 42187 42169 42214 42229 42057 42242 42098 42247 42248 42196 42193 42238 42266 42241 42240 42274 42258 42286 42334 42328 42293 42298 42356 42342 42307 42322 42370 42368 42366 42376 42352 42389 42365 42403 42416 42429 42414 42043 42359 42438

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Albania, Andorra, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan Palestine, State of Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam.

device · product 8 of 12

Ingenia Elition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781357

Z-2418-2021
Recall number
Z-2418-2021
Initiated
August 11, 2021
Classification
Class II
Status
Completed
Recalling firm
Philips North America Llc
Quantity
64 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment

Code information

Serial Number Unique Device Identifier (UDI#) Model: 781357 46029 (01)00884838088108(21)46029 46053 (01)00884838088108(21)46053 46045 (01)00884838088108(21)46045 46027 (01)00884838088108(21)46027 46042 (01)00884838088108(21)46042 46084 (01)00884838088108(21)46084 46086 (01)00884838088108(21)46086 46083 (01)00884838088108(21)46083 46030 (01)00884838088108(21)46030 46031 (01)00884838088108(21)46031 46050 (01)00884838088108(21)46050 46049 (01)00884838088108(21)46049 46052 (01)00884838088108(21)46052 46076 (01)00884838088108(21)46076 46085 (01)00884838088108(21)46085 46024 (01)00884838088108(21)46024 46044 N/A 46061 N/A 46001 (01)00884838088108(21)46001 46005 (01)00884838088108(21)46005 46011 (01)00884838088108(21)46011 46012 (01)00884838088108(21)46012 46057 (01)00884838088108(21)46057 46048 (01)00884838088108(21)46048 46021 (01)00884838088108(21)46021 46066 (01)00884838088108(21)46066 46078 (01)00884838088108(21)46078 46081 (01)00884838088108(21)46081 46060 (01)00884838088108(21)46060 46004 (01)00884838088108(21)46004 46018 (01)00884838088108(21)46018 46020 (01)00884838088108(21)46020 46013 (01)00884838088108(21)46013 46015 (01)00884838088108(21)46015 46017 (01)00884838088108(21)46017 46016 (01)00884838088108(21)46016 46023 (01)00884838088108(21)46023 46033 (01)00884838088108(21)46033 46034 (01)00884838088108(21)46034 46037 (01)00884838088108(21)46037 46025 (01)00884838088108(21)46025 46041 (01)00884838088108(21)46041 46026 (01)00884838088108(21)46026 46032 (01)00884838088108(21)46032 46036 (01)00884838088108(21)46036 46059 (01)00884838088108(21)46059 46039 (01)00884838088108(21)46039 46075 (01)00884838088108(21)46075 46046 (01)00884838088108(21)46046 46068 (01)00884838088108(21)46068 46058 (01)00884838088108(21)46058 46054 (01)00884838088108(21)46054 46082 (01)00884838088108(21)46082 46069 (01)00884838088108(21)46069 46003 (01)00884838088108(21)46003 46019 (01)00884838088108(21)46019 46008 (01)00884838088108(21)46008 46007 (01)00884838088108(21)46007 46067 (01)00884838088108(21)46067 46089 N/A 46002 (01)00884838088108(21)46002 46014 (01)00884838088108(21)46014 46065 (01)00884838088108(21)46065 46077 (01)00884838088108(21)46077

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Albania, Andorra, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan Palestine, State of Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam.

device · product 9 of 12

Ingenia Elition X-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781358

Z-2419-2021
Recall number
Z-2419-2021
Initiated
August 11, 2021
Classification
Class II
Status
Completed
Recalling firm
Philips North America Llc
Quantity
228 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment

Code information

Serial Number Unique Device Identifier (UDI#) Model: 781358 45153 (01)00884838088115(21)45153 45062 (01)00884838088115(21)45062 45107 (01)00884838088115(21)45107 45144 (01)00884838088115(21)45144 45145 (01)00884838088115(21)45145 45142 (01)00884838088115(21)45142 45215 (01)00884838088115(21)45215 45216 (01)00884838088115(21)45216 45284 (01)00884838088115(21)45284 45079 (01)00884838088115(21)45079 45121 (01)00884838088115(21)45121 45007 (01)00884838088115(21)45007 45154 (01)00884838088115(21)45154 45127 (01)00884838088115(21)45127 45052 (01)00884838088115(21)45052 45193 (01)00884838088115(21)45193 45253 (01)00884838088115(21)45253 45042 (01)00884838088115(21)45042 45045 (01)00884838088115(21)45045 45136 (01)00884838088115(21)45136 45119 (01)00884838088115(21)45119 45197 (01)00884838088115(21)45197 45195 (01)00884838088115(21)45195 45097 (01)00884838088115(21)45097 45106 N/A 45131 N/A 45259 (01)00884838088115(21)45259 45300 (01)00884838088115(21)45300 45313 (01)00884838088115(21)45313 45298 (01)00884838088115(21)45298 45265 (01)00884838088115(21)45265 45000 (01)00884838088115 45039 (01)00884838088115(21)45039 45047 (01)00884838088115(21)45047 45080 (01)00884838088115(21)45080 45056 (01)00884838088115(21)45056 45137 (01)00884838088115(21)45137 45129 (01)00884838088115(21)45129 45109 (01)00884838088115(21)45109 45171 (01)00884838088115(21)45171 45205 (01)00884838088115(21)45205 45210 (01)00884838088115(21)45210 45188 (01)00884838088115(21)45188 45297 (01)00884838088115(21)45297 45071 (01)00884838088115(21)45071 45098 (01)00884838088115(21)45098 45140 (01)00884838088115(21)45140 45246 (01)00884838088115(21)45246 45159 (01)00884838088115(21)45159 45031 (01)00884838088115(21)45031 45044 (01)00884838088115(21)45044 45043 (01)00884838088115(21)45043 45040 (01)00884838088115(21)45040 45065 (01)00884838088115(21)45065 45070 (01)00884838088115(21)45070 45260 (01)00884838088115(21)45260 45088 (01)00884838088115(21)45088 45096 (01)00884838088115(21)45096 45128 (01)00884838088115(21)45128 45134 (01)00884838088115(21)45134 45111 (01)00884838088115(21)45111 45190 (01)00884838088115(21)45190 45218 (01)00884838088115(21)45218 45139 (01)00884838088115(21)45139 45241 (01)00884838088115(21)45241 45025 (01)00884838088115(21)45025 45114 (01)00884838088115(21)45114 45151 (01)00884838088115(21)45151 45148 (01)00884838088115(21)45148 45160 (01)00884838088115(21)45160 45176 (01)00884838088115(21)45176 45274 (01)00884838088115(21)45274 45276 (01)00884838088115(21)45276 45282 (01)00884838088115(21)45282 45248 (01)00884838088115(21)45248 45138 (01)00884838088115(21)45138 45295 (01)00884838088115(21)45295 45033 (01)00884838088115(21)45033 45048 (01)00884838088115(21)45048 45037 (01)00884838088115(21)45037 45050 (01)00884838088115(21)45050 45049 (01)00884838088115(21)45049 45046 (01)00884838088115(21)45046 45034 (01)00884838088115(21)45034 45066 (01)00884838088115(21)45066 45061 (01)00884838088115(21)45061 45076 (01)00884838088115(21)45076 45072 (01)00884838088115(21)45072 45077 (01)00884838088115(21)45077 45090 (01)00884838088115(21)45090 45041 (01)00884838088115(21)45041 45091 (01)00884838088115(21)45091 45093 (01)00884838088115(21)45093 45102 (01)00884838088115(21)45102 45105 (01)00884838088115(21)45105 45120 (01)00884838088115(21)45120 45064 (01)00884838088115(21)45064 45084 (01)00884838088115(21)45084 45170 (01)00884838088115(21)45170 45118 (01)00884838088115(21)45118 45163 (01)00884838088115(21)45163 45116 (01)00884838088115(21)45116 45149 (01)00884838088115(21)45149 45141 (01)00884838088115(21)45141 45162 (01)00884838088115(21)45162 45185 (01)00884838088115(21)45185 45115 (01)00884838088115(21)45115 45186 (01)00884838088115(21)45186 45189 (01)00884838088115(21)45189 45211 (01)00884838088115(21)45211 45250 (01)00884838088115(21)45250 45224 (01)00884838088115(21)45224 45272 (01)00884838088115(21)45272 45281 (01)00884838088115(21)45281 45212 (01)00884838088115(21)45212 45231 (01)00884838088115(21)45231 45290 (01)00884838088115(21)45290 45314 (01)00884838088115(21)45314 45323 (01)00884838088115(21)45323 45268 (01)00884838088115(21)45268 45123 (01)00884838088115(21)45123 45122 (01)00884838088115(21)45122 45169 N/A 45168 (01)00884838088115(21)45168 45191 (01)00884838088115(21)45191 45220 (01)00884838088115(21)45220 45204 (01)00884838088115(21)45204 45192 N/A 45229 (01)00884838088115(21)45229 45203 (01)00884838088115(21)45203 45222 (01)00884838088115(21)45222 45228 (01)00884838088115(21)45228 45207 (01)00884838088115(21)45207 45249 (01)00884838088115(21)45249 45279 (01)00884838088115(21)45279 45278 (01)00884838088115(21)45278 45320 (01)00884838088115(21)45320 45156 (01)00884838088115(21)45156 45157 (01)00884838088115(21)45157 45085 (01)00884838088115(21)45085 45303 (01)00884838088115(21)45303 45304 (01)00884838088115(21)45304 45307 (01)00884838088115(21)45307 45305 (01)00884838088115(21)45305 45306 (01)00884838088115(21)45306 45308 (01)00884838088115(21)45308 45309 (01)00884838088115(21)45309 45311 (01)00884838088115(21)45311 45310 (01)00884838088115(21)45310 45312 (01)00884838088115(21)45312 45267 (01)00884838088115(21)45267 45001 (01)00884838088115 45008 (01)00884838088115(21)45008 45009 N/A 45036 (01)00884838088115(21)45036 45181 (01)00884838088115(21)45181 45184 (01)00884838088115(21)45184 45227 (01)00884838088115(21)45227 45217 (01)00884838088115(21)45217 45187 N/A 45292 (01)00884838088115(21)45292 45219 (01)00884838088115(21)45219 45180 (01)00884838088115(21)45180 45067 (01)00884838088115(21)45067 45094 (01)00884838088115(21)45094 45183 (01)00884838088115(21)45183 45081 (01)00884838088115(21)45081 45095 (01)00884838088115(21)45095 45028 (01)00884838088115(21)45028 45029 N/A 45030 (01)00884838088115(21)45030 45165 (01)00884838088115(21)45165 45158 (01)00884838088115(21)45158 45177 (01)00884838088115(21)45177 45174 (01)00884838088115(21)45174 45002 (01)00884838088115 45010 (01)00884838088115(21)45010 45011 (01)00884838088115(21)45011 45026 (01)00884838088115(21)45026 45027 (01)00884838088115(21)45027 45024 (01)00884838088115(21)45024 45035 (01)00884838088115(21)45035 45032 (01)00884838088115(21)45032 45051 (01)00884838088115(21)45051 45054 (01)00884838088115(21)45054 45053 (01)00884838088115(21)45053 45078 (01)00884838088115(21)45078 45068 (01)00884838088115(21)45068 45089 (01)00884838088115(21)45089 45082 (01)00884838088115(21)45082 45055 (01)00884838088115(21)45055 45086 (01)00884838088115(21)45086 45060 (01)00884838088115(21)45060 45100 (01)00884838088115(21)45100 45112 (01)00884838088115(21)45112 45099 (01)00884838088115(21)45099 45075 (01)00884838088115(21)45075 45087 (01)00884838088115(21)45087 45108 (01)00884838088115(21)45108 45113 (01)00884838088115(21)45113 45146 (01)00884838088115(21)45146 45124 (01)00884838088115(21)45124 45147 (01)00884838088115(21)45147 45164 (01)00884838088115(21)45164 45150 (01)00884838088115(21)45150 45133 (01)00884838088115(21)45133 45152 (01)00884838088115(21)45152 45161 (01)00884838088115(21)45161 45178 (01)00884838088115(21)45178 45132 (01)00884838088115(21)45132 45179 (01)00884838088115(21)45179 45194 (01)00884838088115(21)45194 45237 (01)00884838088115(21)45237 45236 (01)00884838088115(21)45236 45238 (01)00884838088115(21)45238 45243 (01)00884838088115(21)45243 45252 (01)00884838088115(21)45252 45245 (01)00884838088115(21)45245 45263 (01)00884838088115(21)45263 45261 (01)00884838088115(21)45261 45269 (01)00884838088115(21)45269 45264 (01)00884838088115(21)45264 45247 (01)00884838088115(21)45247 45296 (01)00884838088115(21)45296 45321 (01)00884838088115(21)45321 45092 (01)00884838088115(21)45092 45155 (01)00884838088115(21)45155 45058 N/A

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Albania, Andorra, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan Palestine, State of Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam.

device · product 10 of 12

Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781271

Z-2420-2021
Recall number
Z-2420-2021
Initiated
August 11, 2021
Classification
Class II
Status
Completed
Recalling firm
Philips North America Llc
Quantity
266 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment

Code information

Serial Number Unique Device Identifier (UDI#) Model: 781271 78121 (01)00884838068452(21)78121 78150 (01)00884838068452(21)78150 78157 (01)00884838068452(21)78157 78096 N/A 78208 (01)00884838068452(21)78208 78094 N/A 78012 N/A 78074 N/A 78154 (01)00884838068452(21)78154 78161 N/A 78172 (01)00884838068452(21)78172 78170 (01)00884838068452(21)78170 78182 (01)00884838068452(21)78182 78183 (01)00884838068452(21)78183 78205 (01)00884838068452(21)78205 78196 (01)00884838068452(21)78196 78171 (01)00884838068452(21)78171 78213 (01)00884838068452(21)78213 78221 (01)00884838068452(21)78221 78210 (01)00884838068452(21)78210 78212 (01)00884838068452(21)78212 78233 (01)00884838068452(21)78233 78190 (01)00884838068452(21)78190 78198 (01)00884838068452(21)78198 78216 (01)00884838068452(21)78216 78225 (01)00884838068452(21)78225 78238 N/A 78242 (01)00884838068452(21)78242 78173 (01)00884838068452(21)78173 78251 (01)00884838068452(21)78251 78250 (01)00884838068452(21)78250 78241 (01)00884838068452(21)78241 78235 (01)00884838068452(21)78235 78262 (01)00884838068452(21)78262 78253 (01)00884838068452(21)78253 78244 (01)00884838068452(21)78244 78252 (01)00884838068452(21)78252 78256 (01)00884838068452(21)78256 78263 (01)00884838068452(21)78263 78257 N/A 78266 (01)00884838068452(21)78266 78267 (01)00884838068452(21)78267 78269 (01)00884838068452(21)78269 78265 (01)00884838068452(21)78265 78270 (01)00884838068452(21)78270 78284 (01)00884838068452(21)78284 78281 (01)00884838068452(21)78281 78289 (01)00884838068452(21)78289 78293 (01)00884838068452(21)78293 78271 (01)00884838068452(21)78271 78218 (01)00884838068452(21)78218 78291 (01)00884838068452(21)78291 78283 (01)00884838068452(21)78283 78273 (01)00884838068452(21)78273 78305 (01)00884838068452(21)78305 78268 (01)00884838068452(21)78268 78282 (01)00884838068452(21)78282 78279 (01)00884838068452(21)78279 78292 (01)00884838068452(21)78292 78309 (01)00884838068452(21)78309 78288 (01)00884838068452(21)78288 78314 (01)00884838068452(21)78314 78306 (01)00884838068452(21)78306 78319 (01)00884838068452(21)78319 78320 (01)00884838068452(21)78320 78307 (01)00884838068452(21)78307 78296 (01)00884838068452(21)78296 78280 (01)00884838068452(21)78280 78313 (01)00884838068452(21)78313 78317 (01)00884838068452(21)78317 78321 (01)00884838068452(21)78321 78322 (01)00884838068452(21)78322 78316 (01)00884838068452(21)78316 78310 (01)00884838068452(21)78310 78308 (01)00884838068452(21)78308 78312 (01)00884838068452(21)78312 78240 (01)00884838068452(21)78240 78329 (01)00884838068452(21)78329 78272 (01)00884838068452(21)78272 78189 (01)00884838068452(21)78189 78330 (01)00884838068452(21)78330 78332 (01)00884838068452(21)78332 78334 (01)00884838068452(21)78334 78340 (01)00884838068452(21)78340 78243 (01)00884838068452(21)78243 78294 (01)00884838068452(21)78294 78335 (01)00884838068452(21)78335 78345 (01)00884838068452(21)78345 78295 (01)00884838068452(21)78295 78333 (01)00884838068452(21)78333 78342 (01)00884838068452(21)78342 78341 (01)00884838068452(21)78341 78327 (01)00884838068452(21)78327 78347 (01)00884838068452(21)78347 78224 (01)00884838068452(21)78224 78030 N/A 78036 N/A 78059 N/A 78156 (01)00884838068452(21)78156 78249 (01)00884838068452(21)78249 78080 (01)00884838068452(21)78080 78078 (01)00884838068452(21)78078 78098 (01)00884838068452(21)78098 78003 N/A 78017 N/A 78065 N/A 78070 N/A 78081 N/A 78076 N/A 78087 N/A 78101 (01)00884838068452(21)78101 78097 (01)00884838068452(21)78097 78104 (01)00884838068452(21)78104 78099 (01)00884838068452(21)78099 78107 (01)00884838068452(21)78107 78126 (01)00884838068452(21)78126 78149 (01)00884838068452(21)78149 78151 (01)00884838068452(21)78151 78181 N/A 78219 (01)00884838068452(21)78219 78206 (01)00884838068452(21)78206 78264 (01)00884838068452(21)78264 78063 N/A 78064 N/A 78106 (01)00884838068452(21)78106 78187 (01)00884838068452(21)78187 78000 N/A 78005 N/A 78007 N/A 78009 N/A 78016 N/A 78015 N/A 78018 N/A 78023 N/A 78019 N/A 78021 N/A 78027 N/A 78010 N/A 78029 N/A 78031 N/A 78025 N/A 78033 N/A 78032 N/A 78038 N/A 78035 N/A 78039 N/A 78040 N/A 78045 N/A 78043 N/A 78042 N/A 78049 N/A 78048 N/A 78050 N/A 78051 N/A 78062 N/A 78068 (01)00884838068452(21)78068 78067 N/A 78072 (01)00884838068452(21)78072 78084 N/A 78089 (01)00884838068452(21)78089 78082 N/A 78083 (01)00884838068452(21)78083 78091 (01)00884838068452(21)78091 78095 (01)00884838068452(21)78095 78088 (01)00884838068452(21)78088 78100 (01)00884838068452(21)78100 78111 N/A 78115 (01)00884838068452(21)78115 78117 (01)00884838068452(21)78117 78113 (01)00884838068452(21)78113 78114 (01)00884838068452(21)78114 78109 (01)00884838068452(21)78109 78132 (01)00884838068452(21)78132 78127 (01)00884838068452(21)78127 78133 (01)00884838068452(21)78133 78139 (01)00884838068452(21)78139 78140 (01)00884838068452(21)78140 78129 (01)00884838068452(21)78129 78147 (01)00884838068452(21)78147 78148 (01)00884838068452(21)78148 78145 (01)00884838068452(21)78145 78155 (01)00884838068452(21)78155 78203 (01)00884838068452(21)78203 78199 (01)00884838068452(21)78199 78207 (01)00884838068452(21)78207 78222 (01)00884838068452(21)78222 78223 (01)00884838068452(21)78223 78214 (01)00884838068452(21)78214 78011 N/A 78014 N/A 78013 N/A 78028 N/A 78034 N/A 78044 N/A 78047 N/A 78046 N/A 78073 N/A 78058 N/A 78071 (01)00884838068452(21)78071 78086 N/A 78075 N/A 78066 N/A 78060 (01)00884838068452(21)78060 78092 (01)00884838068452(21)78092 78102 (01)00884838068452(21)78102 78077 (01)00884838068452(21)78077 78110 (01)00884838068452(21)78110 78112 (01)00884838068452(21)78112 78103 (01)00884838068452(21)78103 78120 (01)00884838068452(21)78120 78122 (01)00884838068452(21)78122 78123 (01)00884838068452(21)78123 78128 (01)00884838068452(21)78128 78118 (01)00884838068452(21)78118 78135 (01)00884838068452(21)78135 78142 (01)00884838068452(21)78142 78141 (01)00884838068452(21)78141 78158 (01)00884838068452(21)78158 78162 (01)00884838068452(21)78162 78165 (01)00884838068452(21)78165 78167 (01)00884838068452(21)78167 78138 (01)00884838068452(21)78138 78164 (01)00884838068452(21)78164 78166 (01)00884838068452(21)78166 78175 (01)00884838068452(21)78175 78180 (01)00884838068452(21)78180 78186 (01)00884838068452(21)78186 78188 (01)00884838068452(21)78188 78137 (01)00884838068452(21)78137 78195 (01)00884838068452(21)78195 78197 (01)00884838068452(21)78197 78209 (01)00884838068452(21)78209 78193 (01)00884838068452(21)78193 78201 (01)00884838068452(21)78201 78215 (01)00884838068452(21)78215 78217 (01)00884838068452(21)78217 78202 (01)00884838068452(21)78202 78232 (01)00884838068452(21)78232 78194 (01)00884838068452(21)78194 78227 (01)00884838068452(21)78227 78234 (01)00884838068452(21)78234 78255 (01)00884838068452(21)78255 78254 (01)00884838068452(21)78254 78247 (01)00884838068452(21)78247 78259 (01)00884838068452(21)78259 78239 (01)00884838068452(21)78239 78260 (01)00884838068452(21)78260 78261 (01)00884838068452(21)78261 78287 (01)00884838068452(21)78287 78286 (01)00884838068452(21)78286 78299 (01)00884838068452(21)78299 78290 (01)00884838068452(21)78290 78298 (01)00884838068452(21)78298 78297 (01)00884838068452(21)78297 78229 (01)00884838068452(21)78229 78277 (01)00884838068452(21)78277 78326 (01)00884838068452(21)78326 78337 (01)00884838068452(21)78337 78324 (01)00884838068452(21)78324 78336 (01)00884838068452(21)78336 78004 N/A 78008 N/A 78053 N/A 78026 N/A 78022 N/A

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Albania, Andorra, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan Palestine, State of Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam.

device · product 11 of 12

SmartPath to dStream for XR and 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781270

Z-2421-2021
Recall number
Z-2421-2021
Initiated
August 11, 2021
Classification
Class II
Status
Completed
Recalling firm
Philips North America Llc
Quantity
198 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment

Code information

Serial Number Unique Device Identifier (UDI#) Model: 781270 17536 N/A 24013 N/A 17508 N/A 17212 N/A 38184 (01)00884838095083 17546 N/A 38366 N/A 17290 N/A 34060 N/A 35056 N/A 23011 N/A 38076 N/A 38013 N/A 17369 N/A 17286 N/A 17172 N/A 24025 N/A 35031 N/A 17566 N/A 17490 N/A 17360 N/A 24007 N/A 38199 N/A 35042 N/A 38126 N/A 17302 N/A 17429 (01)00884838095083 24108 N/A 17473 N/A 38317 N/A 35043 N/A 35087 N/A 38040 N/A 17544 N/A 34152 N/A 17204 N/A 17339 N/A 38037 N/A 34032 N/A 23030 N/A 35044 N/A 17416 N/A 17440 N/A 38202 N/A 34145 N/A 38192 N/A 17436 N/A 38038 N/A 17398 N/A 17292 N/A 34211 (01)00884838095083 17264 (01)00884838095083 24055 (01)00884838095083 17415 (01)00884838095083 34142 (01)00884838095083 17283 N/A 38084 N/A 38198 N/A 17386 N/A 17006 N/A 17378 N/A 17533 N/A 38062 (01)00884838095083 35073 (01)00884838095083 34080 N/A 38116 N/A 17583 N/A 38214 N/A 38356 N/A 34111 N/A 35052 N/A 17590 N/A 38235 N/A 34037 N/A 38102 N/A 74011 N/A 38023 N/A 17406 (01)00884838095083 38063 N/A 17265 N/A 24036 N/A 35020 N/A 38135 N/A 17247 N/A 17517 (01)00884838095083(21)17517 34107 N/A 35060 N/A 17524 N/A 17514 N/A 24095 N/A 23026 N/A 24087 N/A 34236 (01)00884838095083 34249 (01)00884838095083 17231 N/A 17222 N/A 17308 N/A 17342 N/A 17388 N/A 17559 N/A 24143 N/A 38005 N/A 38014 N/A 38015 N/A 35048 N/A 38041 N/A 38081 N/A 38168 N/A 17242 N/A 38161 N/A 17245 N/A 38089 N/A 17589 N/A 24124 N/A 17499 N/A 17250 N/A 17468 N/A 24012 N/A 17299 N/A 17564 N/A 17565 N/A 24111 N/A 17493 N/A 17309 N/A 17357 (01)00884838095083 24110 (01)00884838095083 17464 (01)00884838095083 34221 (01)00884838095083 24006 (01)00884838095083 17556 (01)00884838095083 24134 (01)00884838095083 24023 (01)00884838095083 34090 (01)00884838095083 38032 (01)00884838095083 24109 (01)00884838095083 17399 (01)00884838095083(21)17399 34246 (01)00884838095083(21)34246 17594 N/A 24117 N/A 34096 N/A 38006 N/A 38417 N/A 38120 N/A 17495 N/A 38263 N/A 34292 N/A 34154 N/A 34233 N/A 17321 N/A 24090 N/A 17471 N/A 17428 N/A 17458 N/A 17194 N/A 38071 N/A 17246 N/A 38134 N/A 38131 N/A 38026 (01)00884838095083 17550 N/A 17610 N/A 17610 N/A 24145 (01)00884838095083 38217 (01)00884838095083 38225 (01)00884838095083 34250 N/A 17237 N/A 24075 N/A 24018 N/A 17326 N/A 17466 N/A 38138 (01)00884838095083 38111 N/A 17356 (01)00884838095083 38065 N/A 38300 N/A 38259 N/A 38045 N/A 23033 N/A 17239 N/A 34019 N/A 35032 N/A 34098 N/A 24076 N/A 34058 N/A 34223 N/A 17240 N/A 35019 N/A 38091 N/A 17375 N/A 17215 N/A 17459 N/A 24058 N/A 24066 N/A 17516 (01)00884838095083 17284 (01)00884838095083 17366 N/A 17352 N/A

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Albania, Andorra, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan Palestine, State of Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam.

device · product 12 of 12

Ingenia Ambition X- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781356

Z-2422-2021
Recall number
Z-2422-2021
Initiated
August 11, 2021
Classification
Class II
Status
Completed
Recalling firm
Philips North America Llc
Quantity
147 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment

Code information

Serial Number Unique Device Identifier (UDI#) Model: 781356 47077 (01)00884838090040(21)47077 47194 (01)00884838090040(21)47194 47091 (01)00884838090040(21)47091 47040 (01)00884838090040(21)47040 47092 (01)00884838090040(21)47092 47048 (01)00884838090040(21)47048 47195 N/A 47050 (01)00884838090040(21)47050 47209 (01)00884838090040(21)47209 47247 (01)00884838090040(21)47247 47293 (01)00884838090040(21)47293 47001 (01)00884838090040 47032 (01)00884838090040(21)47032 47041 (01)00884838090040(21)47041 47086 (01)00884838090040(21)47086 47248 (01)00884838090040(21)47248 47255 (01)00884838090040(21)47255 47258 (01)00884838090040(21)47258 47275 (01)00884838090040(21)47275 47002 (01)00884838090040(21)47002 47003 (01)00884838090040(21)47003 47000 (01)00884838090040(21)47000 47017 (01)00884838090040(21)47017 47047 (01)00884838090040(21)47047 47056 (01)00884838090040(21)47056 47035 (01)00884838090040(21)47035 47020 (01)00884838090040(21)47020 47078 (01)00884838090040(21)47078 47089 (01)00884838090040(21)47089 47024 (01)00884838090040(21)47024 47097 (01)00884838090040(21)47097 47225 (01)00884838090040(21)47225 47074 (01)00884838090040(21)47074 47058 (01)00884838090040(21)47058 47192 (01)00884838090040(21)47192 47049 (01)00884838090040(21)47049 47019 (01)00884838090040(21)47019 47012 (01)00884838090040(21)47012 47221 (01)00884838090040(21)47221 47276 (01)00884838090040(21)47276 47297 N/A 47270 (01)00884838090040(21)47270 47197 (01)00884838090040(21)47197 47013 (01)00884838090040(21)47013 47015 (01)00884838090040(21)47015 47053 N/A 47014 N/A 47065 N/A 47082 N/A 47099 N/A 47268 N/A 47009 (01)00884838090040(21)47009 47023 (01)00884838090040(21)47023 47030 (01)00884838090040(21)47030 47080 (01)00884838090040(21)47080 47083 (01)00884838090040(21)47083 47245 (01)00884838090040(21)47245 47215 (01)00884838090040(21)47215 47222 (01)00884838090040(21)47222 47299 (01)00884838090040(21)47299 47227 (01)00884838090040(21)47227 47226 (01)00884838090040(21)47226 47265 (01)00884838090040(21)47265 47284 (01)00884838090040(21)47284 47307 (01)00884838090040(21)47307 47057 (01)00884838090040(21)47057 47075 (01)00884838090040(21)47075 47174 (01)00884838090040(21)47174 47088 (01)00884838090040(21)47088 47175 (01)00884838090040(21)47175 47193 (01)00884838090040(21)47193 47081 (01)00884838090040(21)47081 47188 (01)00884838090040(21)47188 47052 (01)00884838090040(21)47052 47059 (01)00884838090040(21)47059 47085 (01)00884838090040(21)47085 47072 (01)00884838090040(21)47072 47184 (01)00884838090040(21)47184 47187 (01)00884838090040(21)47187 47262 (01)00884838090040(21)47262 47211 (01)00884838090040(21)47211 47252 (01)00884838090040(21)47252 47304 (01)00884838090040(21)47304 47298 (01)00884838090040(21)47298 47094 (01)00884838090040(21)47094 47064 (01)00884838090040(21)47064 47244 (01)00884838090040(21)47244 47219 (01)00884838090040(21)47219 47220 (01)00884838090040(21)47220 47096 (01)00884838090040(21)47096 47190 (01)00884838090040(21)47190 47264 (01)00884838090040(21)47264 47034 (01)00884838090040(21)47034 47202 (01)00884838090040(21)47202 47016 (01)00884838090040(21)47016 47269 (01)00884838090040(21)47269 47271 (01)00884838090040(21)47271 47272 N/A 47004 (01)00884838090040(21)47004 47026 (01)00884838090040(21)47026 47006 (01)00884838090040(21)47006 47007 (01)00884838090040(21)47007 47018 (01)00884838090040(21)47018 47027 (01)00884838090040(21)47027 47011 (01)00884838090040(21)47011 47037 (01)00884838090040(21)47037 47039 (01)00884838090040(21)47039 47029 (01)00884838090040(21)47029 47038 (01)00884838090040(21)47038 47043 (01)00884838090040(21)47043 47054 (01)00884838090040(21)47054 47022 (01)00884838090040(21)47022 47044 (01)00884838090040(21)47044 47028 (01)00884838090040(21)47028 47070 (01)00884838090040(21)47070 47062 (01)00884838090040(21)47062 47033 (01)00884838090040(21)47033 47067 (01)00884838090040(21)47067 47045 (01)00884838090040(21)47045 47060 (01)00884838090040(21)47060 47025 (01)00884838090040(21)47025 47051 (01)00884838090040(21)47051 47063 (01)00884838090040(21)47063 47061 (01)00884838090040(21)47061 47071 (01)00884838090040(21)47071 47066 (01)00884838090040(21)47066 47084 (01)00884838090040(21)47084 47098 (01)00884838090040(21)47098 47095 (01)00884838090040(21)47095 47198 (01)00884838090040(21)47198 47093 (01)00884838090040(21)47093 47177 (01)00884838090040(21)47177 47196 (01)00884838090040(21)47196 47199 (01)00884838090040(21)47199 47203 (01)00884838090040(21)47203 47206 (01)00884838090040(21)47206 47068 (01)00884838090040(21)47068 47183 (01)00884838090040(21)47183 47279 (01)00884838090040(21)47279 47208 (01)00884838090040(21)47208 47260 (01)00884838090040(21)47260 47282 (01)00884838090040(21)47282 47216 (01)00884838090040(21)47216 47185 (01)00884838090040(21)47185 47233 (01)00884838090040(21)47233 47292 (01)00884838090040(21)47292

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Albania, Andorra, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan Palestine, State of Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam.

Field note

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