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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93200

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

Open FDA event record

Event summary

Timeline bucket
September 21, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
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

10 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 10

CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system

Z-0271-2024
Recall number
Z-0271-2024
Initiated
September 21, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
46 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for units suspended on the ceiling to fail and fall.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for units suspended on the ceiling to fail and fall.

Code information

Model No. 709030 and 709031; UDI: (01)00884838076747(21) SN17000014 , (01)00884838076747(21) 10000020 , (01)00884838076747(21) SN17000130 , (01)00884838076747(21) SN17000123 , (01)00884838076747(21) SN18000021 , (01)00884838076747(21) SN18000001 , (01)00884838076747(21) SN18000075 , (01)00884838076747(21) SN18000002 , (01)00884838076747(21) 10000004 , (01)00884838076747(21) SN17000144 , (01)00884838076747(21) SN17000140 , (01)00884838076747(21) SN18000003 , (01)00884838076747(21) SN18000063 , (01)00884838076747(21) SN18000018 , (01)00884838076747(21) SN18000022 , (01)00884838076747(21) SN18000041 , (01)00884838076747(21) SN18000031 , (01)00884838076747(21) 10001097 , (01)00884838076747(21) 10000056 , (01)00884838076747(21) 28 , (01)00884838076747(21) 10000184 , (01)00884838076747(21) SN19000018 , (01)00884838076747(21) SN19000006 , (01)00884838076747(21) SN19000040 , (01)00884838076747(21) SN19000001 , (01)00884838076747(21) SN19000041 , (01)00884838076747(21) 10000051 , (01)00884838076747(21) 10000000 , (01)00884838076747(21) 10000087 , (01)00884838076747(21) 10001095 , (01)00884838076747(21) 10000122 , (01)00884838076747(21) 10001001 , (01)00884838076747(21) 10000145 , (01)00884838076747(21) 10000152 , (01)00884838076747(21) 10000190 , (01)00884838076747(21) 10001076 , (01)00884838076747(21) SN17000153 , (01)00884838101456(21) 10001054 , (01)00884838101456(21) 10001087 , (01)00884838101456(21) 10001086 , (01)00884838101456(21) 10001159 , (01)00884838101456(21) 10001109 , (01)00884838101456(21) 10001114 , (01)00884838101456(21) 10001171 , (01)00884838101456(21) 10001194 , (01)00884838101456(21) 10001193; Serial No. SN17000014, 10000020, SN17000130, SN17000123, SN18000021, SN18000001, SN18000075, SN18000002, 10000004, SN17000144, SN17000140, SN18000003, SN18000063, SN18000018, SN18000022, SN18000041, SN18000031, 10001097, 10000056, 28, 10000184, SN19000018, SN19000006, SN19000040, SN19000001, SN19000041, 10000051, 10000000, 10000087, 10001095, 10000122, 10001001, 10000145, 10000152, 10000190, 10001076, SN17000153, 10001054, 10001087, 10001086, 10001159, 10001109, 10001114, 10001171, 10001194, 10001193.

Distribution pattern

Nationwide distribution.

device · product 2 of 10

DigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display and export digital radiographic images.

Z-0272-2024
Recall number
Z-0272-2024
Initiated
September 21, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
13 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for units suspended on the ceiling to fail and fall.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for units suspended on the ceiling to fail and fall.

Code information

Model No. 712029 & 712033; UDI: (01)00884838074521(21) SN19000272, (01)00884838074521(21) SN19000213 , (01)00884838074521(21) 10001077, (01)00884838074521(21) SN20000097, (01)00884838074521(21) SN16000074, (01)00884838074521(21) SN15000238, (01)00884838074521(21) SN16000075, (01)00884838074521(21) SN15000367, (01)00884838074521(21) SN18000428, (01)00884838074521(21) SN17000318, (01)00884838074521(21) SN18000309, (01)00884838074521(21) SN18000204; Serial No. SN15000409, SN19000272, SN19000213, 10001077, SN20000097, SN16000074, SN15000238, SN16000075, SN15000367, SN18000428, SN17000318, SN18000309, SN18000204.

Distribution pattern

Nationwide distribution.

device · product 3 of 10

DigitalDiagnost 4 Flex/Value, used to acquire, process, store, display and export digital radiographic images.

Z-0273-2024
Recall number
Z-0273-2024
Initiated
September 21, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
92 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for units suspended on the ceiling to fail and fall.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for units suspended on the ceiling to fail and fall.

Code information

Model No. 712028, 712227, & 712032; UDI: (01)00884838074514(21)SN18000410, (01)00884838074514(21)SN18000253, (01)00884838074514(21)SN18000339, (01)00884838074514(21)SN18000332, (01)00884838074514(21)SN18000448, (01)00884838074514(21)SN18000306, (01)00884838074514(21)SN18000397, (01)00884838074514(21)SN18000366, (01)00884838074514(21)SN18000391, (01)00884838074514(21)SN18000431, (01)00884838074514(21)SN19000191, (01)00884838074514(21)SN19000119, (01)00884838074514(21)SN19000217, (01)00884838074514(21)SN19000109, (01)00884838074514(21)SN19000260, (01)00884838074514(21)SN20000159, (01)00884838074514(21)SN19000328, (01)00884838074514(21)SN20000372, (01)00884838074514(21)SN20000277, (01)00884838074514(21)SN20000003, (01)00884838074514(21)SN20000052, (01)00884838074514(21)SN19000321, (01)00884838074514(21)SN20000039, (01)00884838074514(21)SN20000121, (01)00884838074514(21)SN18000024 , (01)00884838074514(21) SN15000304 , (01)00884838074514(21) SN15000283 , (01)00884838074514(21) SN15000252 , (01)00884838074514(21) SN15000255 , (01)00884838074514(21) SN18000274 , (01)00884838074514(21) SN16000009 , (01)00884838074514(21) SN16000036 , (01)00884838074514(21) SN16000262 , (01)00884838074514(21) SN17000002 , (01)00884838074514(21) SN16000249 , (01)00884838074514(21) SN17000357 , (01)00884838074514(21) SN18000035 , (01)00884838074514(21) SN17000389 , (01)00884838074514(21) SN17000058 , (01)00884838074514(21) SN16000008 , (01)00884838074514(21) SN17000122 , (01)00884838074514(21) SN17000027 , (01)00884838074514(21) SN17000125 , (01)00884838074514(21) SN17000083 , (01)00884838074514(21) SN17000103 , (01)00884838074514(21) SN17000110 , (01)00884838074514(21) SN17000171 , (01)00884838074514(21) SN17000241 , (01)00884838074514(21) SN18000157 , (01)00884838074514(21) SN18000105 , (01)00884838074514(21) SN18000244 , (01)00884838074514(21) SN17000326 , (01)00884838074514(21) SN17000372 , (01)00884838074514(21) SN18000142 , (01)00884838074514(21) SN18000048 , (01)00884838074514(21) SN18000106 , (01)00884838074514(21) SN18000085 , (01)00884838074514(21) SN18000202 , (01)00884838074514(21) SN18000040 , (01)00884838074514(21) SN17000239 , (01)00884838074514(21) SN18000066 , (01)00884838074514(21) SN18000149 , (01)00884838074514(21) SN18000140 , (01)00884838074514(21) SN20000222 , (01)00884838074514(21) 10001088 , (01)00884838074514(21) SN20000169 , (01)00884838074514(21) SN20000075 , (01)00884838074514(21) E1876E3421250195 , (01)00884838074514(21) SN20000223 , (01)00884838074514(21) SN20000342 , (01)00884838074514(21) SN20000397 , (01)00884838074514(21) 10001069 , (01)00884838074514(21) 10001063 , (01)00884838074514(21) SN10001030 , (01)00884838074514(21) SN10001031 , (01)00884838074514(21) SN10001024 , (01)00884838074514(21) 10001094 , (01)00884838074514(21) 10001066 , (01)00884838074514(21) 10001074 , (01)00884838074514(21) 10001071 , (01)00884838074514(21) 10001095 , (01)00884838074514(21) 19000319 , (01)00884838074514(21) 19000321 , (01)00884838074514(21) 19000322 , (01)00884838074514(21) 19000323 , (01)00884838074514(21) SN1600191 , (01)00884838074514(21) 19000328 , (01)00884838074514(21) 19000331; Serial No. SN15000418, SN15000397, SN18000410, SN18000253, SN18000339, SN18000332, SN18000448, SN18000306, SN18000397, SN18000366, SN18000391, SN18000431, SN19000191, SN19000119, SN19000217, SN19000109, SN19000260, SN20000159, SN19000328, SN20000372, SN20000277, SN20000003, SN20000052, SN19000321, SN20000039, SN20000121, SN18000024, SN15000304, SN15000283, SN15000252, SN15000255, SN18000274, SN16000009, SN16000036, SN16000262, SN17000002, SN16000249, SN17000357, SN18000035, SN17000389, SN17000058, SN16000008, SN17000122, SN17000027, SN17000125, SN17000083, SN17000103, SN17000110, SN17000171, SN17000241, SN18000157, SN18000105, SN18000244, SN17000326, SN17000372, SN18000142, SN18000048, SN18000106, SN18000085, SN18000202, SN18000040, SN17000239, SN18000066, SN18000149, SN18000140, SN20000222, 10001088, SN20000169, SN20000075, E1876E3421250195, SN20000223, SN20000342, SN20000397, 10001069, 10001063, SN10001030, SN10001031, SN10001024, 10001094, 10001066, 10001074, 10001071, 10001095, 19000319, 19000321, 19000322, 19000323, SN1600191, 19000328, 19000331, SN18862009, SN18862007.

Distribution pattern

Nationwide distribution.

device · product 4 of 10

DigitalDiagnost 4 High Performance, used to acquire, process, store, display and export digital radiographic images.

Z-0274-2024
Recall number
Z-0274-2024
Initiated
September 21, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
366 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for units suspended on the ceiling to fail and fall.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for units suspended on the ceiling to fail and fall.

Code information

Model No. 712027, 712031 & 712226; UDI: (01)00884838065321(21) SN18000276 , (01)00884838065321(21) SN18000158 , (01)00884838065321(21) SN19000178 , (01)00884838065321(21) SN18000227 , (01)00884838065321(21) SN18000256 , (01)00884838065321(21) SN18000228 , (01)00884838065321(21) SN18000257 , (01)00884838065321(21) SN18000247 , (01)00884838065321(21) SN18000252 , (01)00884838065321(21) SN18000238 , (01)00884838065321(21) SN19000195 , (01)00884838065321(21) SN19000101 , (01)00884838065321(21) SN19000180 , (01)00884838065321(21) SN18000283 , (01)00884838065321(21) SN18000299 , (01)00884838065321(21) SN19000337 , (01)00884838065321(21) SN18000305 , (01)00884838065321(21) SN19000019 , (01)00884838065321(21) SN18000224 , (01)00884838065321(21) SN18000248 , (01)00884838065321(21) SN18000223 , (01)00884838065321(21) SN18000394 , (01)00884838065321(21) SN18000286 , (01)00884838065321(21) SN19000247 , (01)00884838065321(21) SN18000232 , (01)00884838065321(21) SN19000292 , (01)00884838065321(21) SN18000282 , (01)00884838065321(21) SN18000296 , (01)00884838065321(21) SN20000083 , (01)00884838065321(21) SN18000266 , (01)00884838065321(21) SN18000335 , (01)00884838065321(21) SN18000441 , (01)00884838065321(21) SN19000147 , (01)00884838065321(21) SN18000298 , (01)00884838065321(21) SN18000295 , (01)00884838065321(21) SN18000427 , (01)00884838065321(21) SN18000450 , (01)00884838065321(21) SN19000300 , (01)00884838065321(21) SN19000034 , (01)00884838065321(21) SN18000271 , (01)00884838065321(21) SN19000080 , (01)00884838065321(21) SN19000060 , (01)00884838065321(21) SN18000440 , (01)00884838065321(21) SN19000136 , (01)00884838065321(21) SN18000395 , (01)00884838065321(21) SN19000115 , (01)00884838065321(21) SN19000212 , (01)00884838065321(21) SN19000102 , (01)00884838065321(21) SN18000300 , (01)00884838065321(21) SN18000398 , (01)00884838065321(21) SN19000028 , (01)00884838065321(21) SN19000135 , (01)00884838065321(21) 20000001 , (01)00884838065321(21) SN18000413 , (01)00884838065321(21) SN19000256 , (01)00884838065321(21) SN19000336 , (01)00884838065321(21) SN19000172 , (01)00884838065321(21) SN18000447 , (01)00884838065321(21) 10001078 , (01)00884838065321(21) SN19000155 , (01)00884838065321(21) SN19000259 , (01)00884838065321(21) SN19000349 , (01)00884838065321(21) SN18000407 , (01)00884838065321(21) SN19000350 , (01)00884838065321(21) SN19000050 , (01)00884838065321(21) SN19000291 , (01)00884838065321(21) SN19000142 , (01)00884838065321(21) SN18000420 , (01)00884838065321(21) SN19000128 , (01)00884838065321(21) SN19000120 , (01)00884838065321(21) SN19000006 , (01)00884838065321(21) SN19000090 , (01)00884838065321(21) SN19000123 , (01)00884838065321(21) SN19000368 , (01)00884838065321(21) SN19000171 , (01)00884838065321(21) SN19000048 , (01)00884838065321(21) SN19000277 , (01)00884838065321(21) SN19000100 , (01)00884838065321(21) SN19000179 , (01)00884838065321(21) SN19000190 , (01)00884838065321(21) SN19000332 , (01)00884838065321(21) SN19000334 , (01)00884838065321(21) SN19000032 , (01)00884838065321(21) SN19000279 , (01)00884838065321(21) SN19000293 , (01)00884838065321(21) SN19000063 , (01)00884838065321(21) SN19000288 , (01)00884838065321(21) SN19000089 , (01)00884838065321(21) SN19000196 , (01)00884838065321(21) SN19000220 , (01)00884838065321(21) SN19000164 , (01)00884838065321(21) SN19000181 , (01)00884838065321(21) SN19000157 , (01)00884838065321(21) SN19000199 , (01)00884838065321(21) SN19000221 , (01)00884838065321(21) SN19000342 , (01)00884838065321(21) SN19000339 , (01)00884838065321(21) 19000253 , (01)00884838065321(21) SN19000273 , (01)00884838065321(21) SN20000046 , (01)00884838065321(21) SN19000152 , (01)00884838065321(21) SN19000290 , (01)00884838065321(21) SN20000016 , (01)00884838065321(21) SN19000362 , (01)00884838065321(21) SN19000193 , (01)00884838065321(21) SN20000043 , (01)00884838065321(21) SN19000352 , (01)00884838065321(21) SN19000270 , (01)00884838065321(21) SN19000266 , (01)00884838065321(21) SN19000284 , (01)00884838065321(21) SN19000363 , (01)00884838065321(21) SN20000241 , (01)00884838065321(21) SN20000161 , (01)00884838065321(21) SN20000085 , (01)00884838065321(21) SN19000320 , (01)00884838065321(21) SN20000286 , (01)00884838065321(21) SN20000168 , (01)00884838065321(21) SN20000010 , (01)00884838065321(21) SN20000116 , (01)00884838065321(21) SN19000304 , (01)00884838065321(21) SN20000042 , (01)00884838065321(21) SN20000057 , (01)00884838065321(21) SN15000371 , (01)00884838065321(21) SN18000340 , (01)00884838065321(21) SN15000189 , (01)00884838065321(21) SN18000268 , (01)00884838065321(21) SN18000044 , (01)00884838065321(21) SN18000221 , (01)00884838065321(21) SN15000323 , (01)00884838065321(21) SN15000186 , (01)00884838065321(21) SN15000264 , (01)00884838065321(21) SN15000372 , (01)00884838065321(21) SN16000147 , (01)00884838065321(21) SN16000146 , (01)00884838065321(21) SN16000037 , (01)00884838065321(21) SN16000043 , (01)00884838065321(21) SN16000202 , (01)00884838065321(21) SN16000263 , (01)00884838065321(21) SN17000055 , (01)00884838065321(21) SN16000141 , (01)00884838065321(21) SN16000095 , (01)00884838065321(21) SN16000125 , (01)00884838065321(21) SN16000121 , (01)00884838065321(21) SN16000203 , (01)00884838065321(21) SN16000218 , (01)00884838065321(21) SN16000144 , (01)00884838065321(21) SN16000151 , (01)00884838065321(21) SN16000211 , (01)00884838065321(21) SN16000235 , (01)00884838065321(21) SN16000329 , (01)00884838065321(21) SN17000288 , (01)00884838065321(21) SN16000225 , (01)00884838065321(21) SN17000106 , (01)00884838065321(21) SN16000328 , (01)00884838065321(21) SN17000009 , (01)00884838065321(21) SN18000316 , (01)00884838065321(21) SN20000126 , (01)00884838065321(21) SN16000352 , (01)00884838065321(21) SN17000333 , (01)00884838065321(21) SN16000436 , (01)00884838065321(21) SN16000266 , (01)00884838065321(21) SN17000005 , (01)00884838065321(21) SN16000398 , (01)00884838065321(21) SN17000156 , (01)00884838065321(21) SN16000394 , (01)00884838065321(21) SN16000387 , (01)00884838065321(21) SN16000401 , (01)00884838065321(21) SN16000386 , (01)00884838065321(21) SN16000371 , (01)00884838065321(21) SN16000373 , (01)00884838065321(21) SN16000390 , (01)00884838065321(21) SN17000039 , (01)00884838065321(21) SN16000478 , (01)00884838065321(21) SN18000315 , (01)00884838065321(21) SN20000119 , (01)00884838065321(21) SN17000127 , (01)00884838065321(21) SN18000056 , (01)00884838065321(21) SN17000086 , (01)00884838065321(21) SN17000129 , (01)00884838065321(21) SN17000143 , (01)00884838065321(21) SN17000158 , (01)00884838065321(21) SN17000157 , (01)00884838065321(21) SN16000435 , (01)00884838065321(21) SN17000263 , (01)00884838065321(21) SN16000430 , (01)00884838065321(21) SN19000289 , (01)00884838065321(21) SN19000333 , (01)00884838065321(21) SN17000362 , (01)00884838065321(21) SN17000303 , (01)00884838065321(21) SN17000097 , (01)00884838065321(21) SN17000155 , (01)00884838065321(21) SN18000028 , (01)00884838065321(21) SN17000100 , (01)00884838065321(21) SN17000217 , (01)00884838065321(21) SN17000082 , (01)00884838065321(21) SN17000084 , (01)00884838065321(21) SN17000160 , (01)00884838065321(21) SN17000359 , (01)00884838065321(21) SN17000216 , (01)00884838065321(21) SN17000166 , (01)00884838065321(21) SN17000151 , (01)00884838065321(21) SN17000185 , (01)00884838065321(21) SN17000370 , (01)00884838065321(21) SN17000235 , (01)00884838065321(21) SN17000130 , (01)00884838065321(21) SN18000001 , (01)00884838065321(21) SN17000184 , (01)00884838065321(21) SN17000349 , (01)00884838065321(21) SN18000214 , (01)00884838065321(21) SN17000252 , (01)00884838065321(21) SN17000264 , (01)00884838065321(21) SN17000179 , (01)00884838065321(21) SN17000329 , (01)00884838065321(21) SN17000233 , (01)00884838065321(21) SN17000305 , (01)00884838065321(21) SN17000328 , (01)00884838065321(21) SN17000231 , (01)00884838065321(21) SN17000234 , (01)00884838065321(21) SN18000123 , (01)00884838065321(21) SN18000165 , (01)00884838065321(21) SN17000261 , (01)00884838065321(21) SN17000444 , (01)00884838065321(21) SN17000299 , (01)00884838065321(21) SN17000246 , (01)00884838065321(21) SN17000352 , (01)00884838065321(21) SN17000335 , (01)00884838065321(21) SN18000045 , (01)00884838065321(21) SN17000411 , (01)00884838065321(21) SN18000080 , (01)00884838065321(21) SN18000032 , (01)00884838065321(21) SN17000399 , (01)00884838065321(21) SN18000121 , (01)00884838065321(21) SN18000145 , (01)00884838065321(21) SN20000090 , (01)00884838065321(21) SN18000290 , (01)00884838065321(21) SN17000376 , (01)00884838065321(21) SN17000414 , (01)00884838065321(21) SN18000061 , (01)00884838065321(21) SN20000136 , (01)00884838065321(21) 19000252 , (01)00884838065321(21) SN10001026 , (01)00884838065321(21) SN18000153 , (01)00884838065321(21) SN17000422 , (01)00884838065321(21) SN18000374 , (01)00884838065321(21) 10001073 , (01)00884838065321(21) SN18000027 , (01)00884838065321(21) SN18000323 , (01)00884838065321(21) SN18000131 , (01)00884838065321(21) SN18000151 , (01)00884838065321(21) SN19000093 , (01)00884838065321(21) SN18000236 , (01)00884838065321(21) SN18000097 , (01)00884838065321(21) SN18000250 , (01)00884838065321(21) SN18000219 , (01)00884838065321(21) SN18000063 , (01)00884838065321(21) SN18000122 , (01)00884838065321(21) SN19000127 , (01)00884838065321(21) SN18000172 , (01)00884838065321(21) SN19000201 , (01)00884838065321(21) SN18000118 , (01)00884838065321(21) SN18000251 , (01)00884838065321(21) SN18000160 , (01)00884838065321(21) SN18000234 , (01)00884838065321(21) SN18000119 , (01)00884838065321(21) 18000319 , (01)00884838065321(21) SN18000147 , (01)00884838065321(21) SN18000263 , (01)00884838065321(21) SN18000267 , (01)00884838065321(21) SN20000147 , (01)00884838065321(21) SN18000156 , (01)00884838065321(21) SN18000150 , (01)00884838065321(21) SN18000148 , (01)00884838065321(21) SN18000275 , (01)00884838065321(21) SN18000185 , (01)00884838065321(21) SN20000068 , (01)00884838065321(21) SN20000021 , (01)00884838065321(21) SN19000367 , (01)00884838065321(21) SN20000123 , (01)00884838065321(21) SN20000178 , (01)00884838065321(21) SN19000356 , (01)00884838065321(21) SN20000208 , (01)00884838065321(21) 10001090 , (01)00884838065321(21) SN20000172 , (01)00884838065321(21) SN20000145 , (01)00884838065321(21) SN20000272 , (01)00884838065321(21) SN20000171 , (01)00884838065321(21) SN20000179 , (01)00884838065321(21) SN20000177 , (01)00884838065321(21) SN20000170 , (01)00884838065321(21) SN20000297 , (01)00884838065321(21) SN20000298 , (01)00884838065321(21) SN20000301 , (01)00884838065321(21) SN20000271 , (01)00884838065321(21) SN20000211 , (01)00884838065321(21) SN20000268 , (01)00884838065321(21) SN20000409 , (01)00884838065321(21) SN10001035 , (01)00884838065321(21) SN10001007 , (01)00884838065321(21) SN20000267 , (01)00884838065321(21) 10001076 , (01)00884838065321(21) SN20000348 , (01)00884838065321(21) SN10001018 , (01)00884838065321(21) SN10001009 , (01)00884838065321(21) SN20000347 , (01)00884838065321(21) SN10001008 , (01)00884838065321(21) SN20000323 , (01)00884838065321(21) SN20000339 , (01)00884838065321(21) 10001065 , (01)00884838065321(21) SN20000373 , (01)00884838065321(21) SN10001006 , (01)00884838065321(21) 10001072 , (01)00884838065321(21) 10001103 , (01)00884838065321(21) SN20000401 , (01)00884838065321(21) SN10001034 , (01)00884838065321(21) SN10001036 , (01)00884838065321(21) SN10001012 , (01)00884838065321(21) SN10001039 , (01)00884838065321(21) SN10001022 , (01)00884838065321(21) 10001087 , (01)00884838065321(21) SN10001056 , (01)00884838065321(21) 10001070 , (01)00884838065321(21) 10001086 , (01)00884838065321(21) 10001075 , (01)00884838065321(21) 10001091 , (01)00884838065321(21) 10001107 , (01)00884838065321(21) 10001092 , (01)00884838065321(21) 10001108 , (01)00884838065321(21) 10001096 , (01)00884838065321(21) 10001109 , (01)00884838065321(21) 10001099 , (01)00884838065321(21) 10001100 , (01)00884838065321(21) 10001098 , (01)00884838065321(21) SN20000044 , (01)00884838065321(21) 10001111 , (01)00884838065321(21) 10001126 , (01)00884838065321(21) 20010235 , (01)00884838065321(21) 10001115 , (01)00884838065321(21) 10001137 , (01)00884838065321(21) 10001121 , (01)00884838065321(21) 10001117 , (01)00884838065321(21) 10001123 , (01)00884838065321(21) 10001127 , (01)00884838065321(21) 10001119 , (01)00884838065321(21) 10001138 , (01)00884838065321(21) 10001120 , (01)00884838065321(21) 10001129 , (01)00884838065321(21) 10001143 , (01)00884838065321(21) 10001131 , (01)00884838065321(21) 10001134 , (01)00884838065321(21) SN15000180 , (01)00884838065321(21) 10001130 , (01)00884838065321(21) SN17000398 , (01)00884838065321(21) SN15000152 , (01)00884838065321(21) SN19000297 , (01)00884838065321(21) SN20000120 , (01)00884838087354(21)SN18861018, (01)00884838087354(21)SN18861019, (01)00884838087354(21)SN18861022, (01)00884838085671(21)SN19861039, (01)00884838085671(21)SN19861039; Serial No. SN15000410, SN15000417, SN15000435, SN15000265, SN15000185, SN15000110, SN18000276, SN18000158, SN19000178, SN18000227, SN18000256, SN18000228, SN18000257, SN18000247, SN18000252, SN18000238, SN19000195, SN19000101, SN19000180, SN18000283, SN18000299, SN19000337, SN18000305, SN19000019, SN18000224, SN18000248, SN18000223, SN18000394, SN18000286, SN19000247, SN18000232, SN19000292, SN18000282, SN18000296, SN20000083, SN18000266, SN18000335, SN18000441, SN19000147, SN18000298, SN18000295, SN18000427, SN18000450, SN19000300, SN19000034, SN18000271, SN19000080, SN19000060, SN18000440, SN19000136, SN18000395, SN19000115, SN19000212, SN19000102, SN18000300, SN18000398, SN19000028, SN19000135, 20000001, SN18000413, SN19000256, SN19000336, SN19000172, SN18000447, 10001078, SN19000155, SN19000259, SN19000349, SN18000407, SN19000350, SN19000050, SN19000291, SN19000142, SN18000420, SN19000128, SN19000120, SN19000006, SN19000090, SN19000123, SN19000368, SN19000171, SN19000048, SN19000277, SN19000100, SN19000179, SN19000190, SN19000332, SN19000334, SN19000032, SN19000279, SN19000293, SN19000063, SN19000288, SN19000089, SN19000196, SN19000220, SN19000164, SN19000181, SN19000157, SN19000199, SN19000221, SN19000342, SN19000339, 19000253, SN19000273, SN20000046, SN19000152, SN19000290, SN20000016, SN19000362, SN19000193, SN20000043, SN19000352, SN19000270, SN19000266, SN19000284, SN19000363, SN20000241, SN20000161, SN20000085, SN19000320, SN20000286, SN20000168, SN20000010, SN20000116, SN19000304, SN20000042, SN20000057, SN15000371, SN18000340, SN15000189, SN18000268, SN18000044, SN18000221, SN15000323, SN15000186, SN15000264, SN15000372, SN16000147, SN16000146, SN16000037, SN16000043, SN16000202, SN16000263, SN17000055, SN16000141, SN16000095, SN16000125, SN16000121, SN16000203, SN16000218, SN16000144, SN16000151, SN16000211, SN16000235, SN16000329, SN17000288, SN16000225, SN17000106, SN16000328, SN17000009, SN18000316, SN20000126, SN16000352, SN17000333, SN16000436, SN16000266, SN17000005, SN16000398, SN17000156, SN16000394, SN16000387, SN16000401, SN16000386, SN16000371, SN16000373, SN16000390, SN17000039, SN16000478, SN18000315, SN20000119, SN17000127, SN18000056, SN17000086, SN17000129, SN17000143, SN17000158, SN17000157, SN16000435, SN17000263, SN16000430, SN19000289, SN19000333, SN17000362, SN17000303, SN17000097, SN17000155, SN18000028, SN17000100, SN17000217, SN17000082, SN17000084, SN17000160, SN17000359, SN17000216, SN17000166, SN17000151, SN17000185, SN17000370, SN17000235, SN17000130, SN18000001, SN17000184, SN17000349, SN18000214, SN17000252, SN17000264, SN17000179, SN17000329, SN17000233, SN17000305, SN17000328, SN17000231, SN17000234, SN18000123, SN18000165, SN17000261, SN17000444, SN17000299, SN17000246, SN17000352, SN17000335, SN18000045, SN17000411, SN18000080, SN18000032, SN17000399, SN18000121, SN18000145, SN20000090, SN18000290, SN17000376, SN17000414, SN18000061, SN20000136, 19000252, SN10001026, SN18000153, SN17000422, SN18000374, 10001073, SN18000027, SN18000323, SN18000131, SN18000151, SN19000093, SN18000236, SN18000097, SN18000250, SN18000219, SN18000063, SN18000122, SN19000127, SN18000172, SN19000201, SN18000118, SN18000251, SN18000160, SN18000234, SN18000119, 18000319, SN18000147, SN18000263, SN18000267, SN20000147, SN18000156, SN18000150, SN18000148, SN18000275, SN18000185, SN20000068, SN20000021, SN19000367, SN20000123, SN20000178, SN19000356, SN20000208, 10001090, SN20000172, SN20000145, SN20000272, SN20000171, SN20000179, SN20000177, SN20000170, SN20000297, SN20000298, SN20000301, SN20000271, SN20000211, SN20000268, SN20000409, SN10001035, SN10001007, SN20000267, 10001076, SN20000348, SN10001018, SN10001009, SN20000347, SN10001008, SN20000323, SN20000339, 10001065, SN20000373, SN10001006, 10001072, 10001103, SN20000401, SN10001034, SN10001036, SN10001012, SN10001039, SN10001022, 10001087, SN10001056, 10001070, 10001086, 10001075, 10001091, 10001107, 10001092, 10001108, 10001096, 10001109, 10001099, 10001100, 10001098, SN20000044, 10001111, 10001126, 20010235, 10001115, 10001137, 10001121, 10001117, 10001123, 10001127, 10001119, 10001138, 10001120, 10001129, 10001143, 10001131, 10001134, SN15000180, 10001130, SN17000398, SN15000152, SN19000297, SN20000120, SN18861018, SN18861015, SN18861019, SN18861022, SN19861039.

Distribution pattern

Nationwide distribution.

device · product 5 of 10

DigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, display and export digital radiographic images.

Z-0275-2024
Recall number
Z-0275-2024
Initiated
September 21, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
33 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for units suspended on the ceiling to fail and fall.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for units suspended on the ceiling to fail and fall.

Code information

Model No. 712035; UDI: (01)00884838090705(21)10000009, (01)00884838090705(21)10000010, (01)00884838090705(21)10000003, (01)00884838090705(21)10000004, (01)00884838090705(21)10000002, (01)00884838090705(21)10000001, (01)00884838090705(21)10000053 , (01)00884838090705(21) 10001042 , (01)00884838090705(21) 10001044 , (01)00884838090705(21) 10001125 , (01)00884838090705(21) 10001113 , (01)00884838090705(21) 10001111 , (01)00884838090705(21) 10001112 , (01)00884838090705(21) 10001109 , (01)00884838090705(21) 10001110 , (01)00884838090705(21) 10001114 , (01)00884838090705(21) 21862107 , (01)00884838090705(21) 10001130 , (01)00884838090705(21) 21862103 , (01)00884838090705(21) 21862101 , (01)00884838090705(21) 21862100 , (01)00884838090705(21) 22860370 , (01)00884838090705(21) 21862123 , (01)00884838090705(21) 21862126 , (01)00884838090705(21) 22860323 , (01)00884838090705(21) 22860045 , (01)00884838090705(21) 22860317 , (01)00884838090705(21) 22860316 , (01)00884838090705(21) 22860318 , (01)00884838090705(21) 22860342 , (01)00884838090705(21) 22860357 , (01)00884838090705(21) 23860320 , (01)00884838090705(21) 23860316; Serial No. 10000009, 10000010, 10000003, 10000004, 10000002, 10000001, 10000053, 10001042, 10001044, 10001125, 10001113, 10001111, 10001112, 10001109, 10001110, 10001114, 21862107, 10001130, 21862103, 21862101, 21862100, 22860370, 21862123, 21862126, 22860323, 22860045, 22860317, 22860316, 22860318, 22860342, 22860357, 23860320, 23860316.

Distribution pattern

Nationwide distribution.

device · product 6 of 10

DigitalDiagnost C90 High Performance, used to acquire, process, store, display and export digital radiographic images.

Z-0276-2024
Recall number
Z-0276-2024
Initiated
September 21, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
143 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for units suspended on the ceiling to fail and fall.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for units suspended on the ceiling to fail and fall.

Code information

Model No. 712034; UDI:(01)00884838090699(21)SN19000013, (01)00884838090699(21)10000203, (01)00884838090699(21)10000008, (01)00884838090699(21)10000030, (01)00884838090699(21)10000043, (01)00884838090699(21)10000037, (01)00884838090699(21)19861128, (01)00884838090699(21)19861129, (01)00884838090699(21)10000064, (01)00884838090699(21)19861143, (01)00884838090699(21)10000024, (01)00884838090699(21)SN10001001, (01)00884838090699(21)10001043, (01)00884838090699(21)10000077, (01)00884838090699(21)10000076, (01)00884838090699(21)10000104, (01)00884838090699(21)10000102, (01)00884838090699(21)10000126 , (01)00884838090699(21) 10000185 , (01)00884838090699(21) 10001084 , (01)00884838090699(21) 22860136 , (01)00884838090699(21) 10001144 , (01)00884838090699(21) 19861160 , (01)00884838090699(21) 10000198 , (01)00884838090699(21) 22860421 , (01)00884838090699(21) SN10001002 , (01)00884838090699(21) 10000212 , (01)00884838090699(21) 19861136 , (01)00884838090699(21) 10001057 , (01)00884838090699(21) 19861165 , (01)00884838090699(21) 10000196 , (01)00884838090699(21) 19861199 , (01)00884838090699(21) 19861197 , (01)00884838090699(21) 19861215 , (01)00884838090699(21) 19861233 , (01)00884838090699(21) 10001106 , (01)00884838090699(21) 10001154 , (01)00884838090699(21) 19861265 , (01)00884838090699(21) 10001104 , (01)00884838090699(21) 10001040 , (01)00884838090699(21) 10001042 , (01)00884838090699(21) 10001019 , (01)00884838090699(21) 10001018 , (01)00884838090699(21) 10001052 , (01)00884838090699(21) 21861498 , (01)00884838090699(21) 10001124 , (01)00884838090699(21) 21861529 , (01)00884838090699(21) 10001114 , (01)00884838090699(21) 10001126 , (01)00884838090699(21) 21861493 , (01)00884838090699(21) 10001109 , (01)00884838090699(21) 10001130 , (01)00884838090699(21) 10001135 , (01)00884838090699(21) 10001203 , (01)00884838090699(21) 10001155 , (01)00884838090699(21) 21861460 , (01)00884838090699(21) 10001145 , (01)00884838090699(21) 10001270 , (01)00884838090699(21) 10001191 , (01)00884838090699(21) 10001178 , (01)00884838090699(21) 10001275 , (01)00884838090699(21) 10001182 , (01)00884838090699(21) 10001169 , (01)00884838090699(21) 10001183 , (01)00884838090699(21) 10001199 , (01)00884838090699(21) 10001192 , (01)00884838090699(21) 21861398 , (01)00884838090699(21) 21861536 , (01)00884838090699(21) 21861503 , (01)00884838090699(21) 21861399 , (01)00884838090699(21) 10001179 , (01)00884838090699(21) 22860037 , (01)00884838090699(21) 10001208 , (01)00884838090699(21) 10001232 , (01)00884838090699(21) 10001215 , (01)00884838090699(21) 22860041 , (01)00884838090699(21) 10001216 , (01)00884838090699(21) 10001264 , (01)00884838090699(21) 22860038 , (01)00884838090699(21) 10001231 , (01)00884838090699(21) 10001236 , (01)00884838090699(21) 10001240 , (01)00884838090699(21) 10001234 , (01)00884838090699(21) 10001251 , (01)00884838090699(21) 10001241 , (01)00884838090699(21) 21861456 , (01)00884838090699(21) 22860442 , (01)00884838090699(21) 21861471 , (01)00884838090699(21) 21861532 , (01)00884838090699(21) 21861418 , (01)00884838090699(21) 21861531 , (01)00884838090699(21) 21861402 , (01)00884838090699(21) 22860064 , (01)00884838090699(21) 22860126 , (01)00884838090699(21) 21861540 , (01)00884838090699(21) 22860063 , (01)00884838090699(21) 22860117 , (01)00884838090699(21) 21861497 , (01)00884838090699(21) 21861496 , (01)00884838090699(21) 21861542 , (01)00884838090699(21) 21861525 , (01)00884838090699(21) 22860052 , (01)00884838090699(21) 22860050 , (01)00884838090699(21) 22860051 , (01)00884838090699(21) 22860075 , (01)00884838090699(21) 22860076 , (01)00884838090699(21) 22860072 , (01)00884838090699(21) 22860154 , (01)00884838090699(21) 22860104 , (01)00884838090699(21) 22860342 , (01)00884838090699(21) 22860060 , (01)00884838090699(21) 22860501 , (01)00884838090699(21) 22860077 , (01)00884838090699(21) 22860097 , (01)00884838090699(21) 22860326 , (01)00884838090699(21) 22860305 , (01)00884838090699(21) 22860155 , (01)00884838090699(21) 22860161 , (01)00884838090699(21) 22860370 , (01)00884838090699(21) 22860374 , (01)00884838090699(21) 22860469 , (01)00884838090699(21) 22860432 , (01)00884838090699(21) 22860436 , (01)00884838090699(21) 22860407 , (01)00884838090699(21) 22860519 , (01)00884838090699(21) 22860531 , (01)00884838090699(21) 22860477 , (01)00884838090699(21) 23860432 , (01)00884838090699(21) 22860634 , (01)00884838090699(21) 22860625 , (01)00884838090699(21) 22860615 , (01)00884838090699(21) 10001125 , (01)00884838090699(21) 22860580 , (01)00884838090699(21) 10001261 , (01)00884838090699(21) 10001128 , (01)00884838090699(21) 23860317 , (01)00884838090699(21) 10001180 , (01)00884838090699(21) 23860376 , (01)00884838090699(21) 22860360 , (01)00884838090699(21) 23860389 , (01)00884838090699(21) 23860518 , (01)00884838090699(21) 10000177 , (01)00884838090699(21) 22860451; Serial No. SN19000013, 10000203, 10000008, 10000030, 10000043, 10000037, 19861128, 19861129, 10000064, 19861143, 10000024, SN10001001, 10001043, 10000077, 10000076, 10000104, 10000102, 10000126, 10000185, 10001084, 22860136, 10001144, 19861160, 10000198, 22860421, SN10001002, 10000212, 19861136, 10001057, 19861165, 10000196, 19861199, 19861197, 19861215, 19861233, 10001106, 10001154, 19861265, 10001104, 10001040, 10001042, 10001019, 10001018, 10001052, 21861498, 10001124, 21861529, 10001114, 10001126, 21861493, 10001109, 10001130, 10001135, 10001203, 10001155, 21861460, 10001145, 10001270, 10001191, 10001178, 10001275, 10001182, 10001169, 10001183, 10001199, 10001192, 21861398, 21861536, 21861503, 21861399, 10001179, 22860037, 10001208, 10001232, 10001215, 22860041, 10001216, 10001264, 22860038, 10001231, 10001236, 10001240, 10001234, 10001251, 10001241, 21861456, 22860442, 21861471, 21861532, 21861418, 21861531, 21861402, 22860064, 22860126, 21861540, 22860063, 22860117, 21861497, 21861496, 21861542, 21861525, 22860052, 22860050, 22860051, 22860075, 22860076, 22860072, 22860154, 22860104, 22860342, 22860060, 22860501, 22860077, 22860097, 22860326, 22860305, 22860155, 22860161, 22860370, 22860374, 22860469, 22860432, 22860436, 22860407, 22860519, 22860531, 22860477, 23860432, 22860634, 22860625, 22860615, 10001125, 22860580, 10001261, 10001128, 23860317, 10001180, 23860376, 22860360, 23860389, 23860518, 10000177, 22860451.

Distribution pattern

Nationwide distribution.

device · product 7 of 10

DigitalDiagnost C90 Release 3, used to acquire, process, store, display and export digital radiographic images.

Z-0277-2024
Recall number
Z-0277-2024
Initiated
September 21, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for units suspended on the ceiling to fail and fall.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for units suspended on the ceiling to fail and fall.

Code information

Model No. 712025; Serial No. SN13000328.

Distribution pattern

Nationwide distribution.

device · product 8 of 10

DigitalDiagnost C90 Release 3.1, used to acquire, process, store, display and export digital radiographic images.

Z-0278-2024
Recall number
Z-0278-2024
Initiated
September 21, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for units suspended on the ceiling to fail and fall.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for units suspended on the ceiling to fail and fall.

Code information

Model No. 712026; Serial No. SN14000197 & SN14000260.

Distribution pattern

Nationwide distribution.

device · product 9 of 10

EasyDiagnost Eleva DRF, Release 5, used to acquire, process, store, display and export digital radiographic images.

Z-0279-2024
Recall number
Z-0279-2024
Initiated
September 21, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
40 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for units suspended on the ceiling to fail and fall.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for units suspended on the ceiling to fail and fall.

Code information

Model No. 706050; UDI: (01)00884838074255(21) SN17000007 , (01)00884838074255(21) SN16000025 , (01)00884838074255(21) SN15000051 , (01)00884838074255(21) SN15000049 , (01)00884838074255(21) SN15000056 , (01)00884838074255(21) SN15000055 , (01)00884838074255(21) SN16000046 , (01)00884838074255(21) SN16000041 , (01)00884838074255(21) SN16000011 , (01)00884838074255(21) SN16000029 , (01)00884838074255(21) SN16000024 , (01)00884838074255(21) SN16000028 , (01)00884838074255(21) SN16000042 , (01)00884838074255(21) SN16000030 , (01)00884838074255(21) SN16000044 , (01)00884838074255(21) SN16000051 , (01)00884838074255(21) SN17000001 , (01)00884838074255(21) SN16000049 , (01)00884838074255(21) SN16000043 , (01)00884838074255(21) SN16000061 , (01)00884838074255(21) SN17000003 , (01)00884838074255(21) SN16000052 , (01)00884838074255(21) SN16000056 , (01)00884838074255(21) SN17000011 , (01)00884838074255(21) SN17000002 , (01)00884838074255(21) SN17000025 , (01)00884838074255(21) SN17000006 , (01)00884838074255(21) SN17000031 , (01)00884838074255(21) SN17000028 , (01)00884838074255(21) SN17000038 , (01)00884838074255(21) SN17000022 , (01)00884838074255(21) SN18000009 , (01)00884838074255(21) SN17000035 , (01)00884838074255(21) SN17000027 , (01)00884838074255(21) SN17000026 , (01)00884838074255(21) SN18000004 , (01)00884838074255(21) SN18000008 , (01)00884838074255(21) SN18000002 , (01)00884838074255(21) SN18000001 , (01)00884838074255(21) SN15000014; Serial No. SN17000007, SN16000025, SN15000051, SN15000049, SN15000056, SN15000055, SN16000046, SN16000041, SN16000011, SN16000029, SN16000024, SN16000028, SN16000042, SN16000030, SN16000044, SN16000051, SN17000001, SN16000049, SN16000043, SN16000061, SN17000003, SN16000052, SN16000056, SN17000011, SN17000002, SN17000025, SN17000006, SN17000031, SN17000028, SN17000038, SN17000022, SN18000009, SN17000035, SN17000027, SN17000026, SN18000004, SN18000008, SN18000002, SN18000001, SN15000014.

Distribution pattern

Nationwide distribution.

device · product 10 of 10

ProxiDiagnost N90, Radiography and Fluoroscopy (R/F) system

Z-0280-2024
Recall number
Z-0280-2024
Initiated
September 21, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
101 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for units suspended on the ceiling to fail and fall.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for units suspended on the ceiling to fail and fall.

Code information

Model No. 706100 & 706110; UDI: (01)00884838085619(21) SN18000019 , (01)00884838085619(21) SN18000019 , (01)00884838085619(21) SN18000002 , (01)00884838085619(21) 721815121706 , (01)00884838085619(21) 10000015 , (01)00884838085619(21) SN18000014 , (01)00884838085619(21) 20000070 , (01)00884838085619(21) SN19000007 , (01)00884838085619(21) 10000035 , (01)00884838085619(21) 10000011 , (01)00884838085619(21) SN18000021 , (01)00884838085619(21) SN19000002 , (01)00884838085619(21) SN19000001 , (01)00884838085619(21) 10000021 , (01)00884838085619(21) 20000054 , (01)00884838085619(21) SN19000006 , (01)00884838085619(21) SN19000011 , (01)00884838085619(21) SN19000012 , (01)00884838085619(21) SN19000005 , (01)00884838085619(21) 10000051 , (01)00884838085619(21) 20000078 , (01)00884838085619(21) 10000050 , (01)00884838085619(21) 20000045 , (01)00884838085619(21) 10000008 , (01)00884838085619(21) SN19000018 , (01)00884838085619(21) 10000017 , (01)00884838085619(21) 10000045 , (01)00884838085619(21) SN19000017 , (01)00884838085619(21) SN19000014 , (01)00884838085619(21) 10000013 , (01)00884838085619(21) 10000010 , (01)00884838085619(21) 10000031 , (01)00884838085619(21) 10000030 , (01)00884838085619(21) 10000018 , (01)00884838085619(21) 10000024 , (01)00884838085619(21) 10000020 , (01)00884838085619(21) 10000025 , (01)00884838085619(21) 10000026 , (01)00884838085619(21) 10000028 , (01)00884838085619(21) SN10001008 , (01)00884838085619(21) 10000036 , (01)00884838085619(21) 10000037 , (01)00884838085619(21) 10000043 , (01)00884838085619(21) 20000026 , (01)00884838085619(21) SN10001004 , (01)00884838085619(21) 10000052 , (01)00884838085619(21) 20000051 , (01)00884838085619(21) 10001028 , (01)00884838085619(21) 10000040 , (01)00884838085619(21) 20000086 , (01)00884838085619(21) 20000052 , (01)00884838085619(21) 20000079 , (01)00884838085619(21) 20000068 , (01)00884838085619(21) 10001022 , (01)00884838085619(21) 20000089 , (01)00884838085619(21) 10001036 , (01)00884838085619(21) SN10001007 , (01)00884838085619(21) 10000023 , (01)00884838085619(21) SN10001002 , (01)00884838085619(21) 10001040 , (01)00884838085619(21) 10001046 , (01)00884838085619(21) 10001023 , (01)00884838085619(21) 10001027 , (01)00884838085619(21) 10001109 , (01)00884838085619(21) 10001026 , (01)00884838085619(21) 10001042 , (01)00884838085619(21) 10001044 , (01)00884838085619(21) 10001051 , (01)00884838085619(21) 20000063 , (01)00884838085619(21) 721815121708 , (01)00884838103221(21) 10001158 , (01)00884838103221(21) 10001158 , (01)00884838103221(21) 10001052 , (01)00884838103221(21) 10001098 , (01)00884838103221(21) 10001061 , (01)00884838103221(21) 10001074 , (01)00884838103221(21) 10001102 , (01)00884838103221(21) 10001060 , (01)00884838103221(21) 10001065 , (01)00884838103221(21) 10001059 , (01)00884838103221(21) 10001067 , (01)00884838103221(21) 10001073 , (01)00884838103221(21) 10001072 , (01)00884838103221(21) 10001089 , (01)00884838103221(21) 10001078 , (01)00884838103221(21) 10001075 , (01)00884838103221(21) 10001105 , (01)00884838103221(21) 10001093 , (01)00884838103221(21) 10001085 , (01)00884838103221(21) 10001101 , (01)00884838103221(21) 10001086 , (01)00884838103221(21) 10001100 , (01)00884838103221(21) 10001091 , (01)00884838103221(21) 10001121 , (01)00884838103221(21) 10001077 , (01)00884838103221(21) 10001096 , (01)00884838103221(21) 10001136 , (01)00884838103221(21) 10001149 , (01)00884838103221(21) 10001150 , (01)00884838103221(21) 10001116 , (01)00884838103221(21) 10001109; Serial No. SN18000019, SN18000019, SN18000002, 721815121706, 10000015, SN18000014, 20000070, SN19000007, 10000035, 10000011, SN18000021, SN19000002, SN19000001, 10000021, 20000054, SN19000006, SN19000011, SN19000012, SN19000005, 10000051, 20000078, 10000050, 20000045, 10000008, SN19000018, 10000017, 10000045, SN19000017, SN19000014, 10000013, 10000010, 10000031, 10000030, 10000018, 10000024, 10000020, 10000025, 10000026, 10000028, SN10001008, 10000036, 10000037, 10000043, 20000026, SN10001004, 10000052, 20000051, 10001028, 10000040, 20000086, 20000052, 20000079, 20000068, 10001022, 20000089, 10001036, SN10001007, 10000023, SN10001002, 10001040, 10001046, 10001023, 10001027, 10001109, 10001026, 10001042, 10001044, 10001051, 20000063, 721815121708, 10001158, 10001158, 10001052, 10001098, 10001061, 10001074, 10001102, 10001060, 10001065, 10001059, 10001067, 10001073, 10001072, 10001089, 10001078, 10001075, 10001105, 10001093, 10001085, 10001101, 10001086, 10001100, 10001091, 10001121, 10001077, 10001096, 10001136, 10001149, 10001150, 10001116, 10001109.

Distribution pattern

Nationwide distribution.

Field note

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