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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93640

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 30, 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

1 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 1

Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.

Z-0725-2024
Recall number
Z-0725-2024
Initiated
November 30, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
197 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Multiple software issues that affect device functionality.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Multiple software issues that affect device functionality.

Code information

Model No. 728333 and 728340; Unique Device Identifier (UDI) (01)00884838101111(21)10148, (01)00884838101111(21)10158, (01)00884838101111(21)10160, (01)00884838101111(21)10162, (01)00884838101111(21)10163, (01)00884838101111(21)10165, (01)00884838101111(21)10166, (01)00884838101111(21)10167, (01)00884838111103(21)397002, (01)00884838111103(21)397003, (01)00884838111103(21)397004, (01)00884838111103(21)397005, (01)00884838111103(21)397006, (01)00884838111103(21)397007, (01)00884838111103(21)397008, (01)00884838111103(21)397009, (01)00884838111103(21)397010, (01)00884838111103(21)397011, (01)00884838111103(21)397013, (01)00884838111103(21)397014, (01)00884838111103(21)397015, (01)00884838101111(21)10021, (01)00884838101111(21)10034, (01)00884838101111(21)10035, (01)00884838101111(21)10036, (01)00884838101111(21)10038, (01)00884838101111(21)10039, (01)00884838101111(21)10042, (01)00884838101111(21)10048, (01)00884838101111(21)10049, (01)00884838101111(21)10052, (01)00884838101111(21)10055, (01)00884838101111(21)10057, (01)00884838101111(21)10067, (01)00884838101111(21)10068, (01)00884838101111(21)10069, (01)00884838101111(21)10081, (01)00884838101111(21)10082, (01)00884838101111(21)10085, (01)00884838101111(21)10087, (01)00884838101111(21)10088, (01)00884838101111(21)10089, (01)00884838101111(21)10091, (01)00884838101111(21)10092, (01)00884838101111(21)10093, (01)00884838101111(21)10096, (01)00884838101111(21)10098, (01)00884838101111(21)10100, (01)00884838101111(21)10102, (01)00884838101111(21)10103, (01)00884838101111(21)10104, (01)00884838101111(21)10105, (01)00884838101111(21)10106, (01)00884838101111(21)10107, (01)00884838101111(21)10108, (01)00884838101111(21)10109, (01)00884838101111(21)10111, (01)00884838101111(21)10112, (01)00884838101111(21)10113, (01)00884838101111(21)10116, (01)00884838101111(21)10119, (01)00884838101111(21)10120, (01)00884838101111(21)10125, (01)00884838101111(21)10126, (01)00884838101111(21)10127, (01)00884838101111(21)10128, (01)00884838101111(21)10131, (01)00884838101111(21)10132, (01)00884838101111(21)10133, (01)00884838101111(21)10134, (01)00884838101111(21)10136, (01)00884838101111(21)10137, (01)00884838101111(21)10138, (01)00884838101111(21)10140, (01)00884838101111(21)10141, (01)00884838101111(21)10142, (01)00884838101111(21)10143, (01)00884838101111(21)10144, (01)00884838101111(21)10145, (01)00884838101111(21)10147, (01)00884838101111(21)10149, (01)00884838101111(21)10151, (01)00884838101111(21)10152, (01)00884838101111(21)10168, (01)00884838101111(21)10171, (01)00884838111103(21)397016, (01)00884838111103(21)397019, (01)00884838111103(21)397018, (01)00884838111103(21)397017, (01)00884838111103(21)397020, (01)00884838111103(21)397021, (01)00884838101111(21)10182, (01)00884838101111(21)10173, (01)00884838101111(21)10174, (01)00884838111103(21)397022, (01)00884838101111(21)10186, (01)00884838111103(21)397024, (01)00884838111103(21)397025, (01)00884838101111(21)10187, (01)00884838111103(21)397027, (01)00884838111103(21)397028, (01)00884838101111(21)10193, (01)00884838101111(21)10155, (01)00884838101111(21)10156, (01)00884838101111(21)10159, (01)00884838101111(21)10161, (01)00884838101111(21)10164, (01)00884838111103(21)397012, (01)00884838101111(21)10013, (01)00884838101111(21)10014, (01)00884838101111(21)10015, (01)00884838101111(21)10016, (01)00884838101111(21)10017, (01)00884838101111(21)10018, (01)00884838101111(21)10019, (01)00884838101111(21)10020, (01)00884838101111(21)10022, (01)00884838101111(21)10023, (01)00884838101111(21)10024, (01)00884838101111(21)10025, (01)00884838101111(21)10031, (01)00884838101111(21)10032, (01)00884838101111(21)10033, (01)00884838101111(21)10040, (01)00884838101111(21)10041, (01)00884838101111(21)10043, (01)00884838101111(21)10044, (01)00884838101111(21)10045, (01)00884838101111(21)10046, (01)00884838101111(21)10047, (01)00884838101111(21)10050, (01)00884838101111(21)10051, (01)00884838101111(21)10053, (01)00884838101111(21)10056, (01)00884838101111(21)10058, (01)00884838101111(21)10059, (01)00884838101111(21)10060, (01)00884838101111(21)10061, (01)00884838101111(21)10062, (01)00884838101111(21)10063, (01)00884838101111(21)10065, (01)00884838101111(21)10066, (01)00884838101111(21)10070, (01)00884838101111(21)10071, (01)00884838101111(21)10072, (01)00884838101111(21)10074, (01)00884838101111(21)10075, (01)00884838101111(21)10076, (01)00884838101111(21)10077, (01)00884838101111(21)10078, (01)00884838101111(21)10079, (01)00884838101111(21)10080, (01)00884838101111(21)10084, (01)00884838101111(21)10086, (01)00884838101111(21)10090, (01)00884838101111(21)10094, (01)00884838101111(21)10095, (01)00884838101111(21)10097, (01)00884838101111(21)10099, (01)00884838101111(21)10101, (01)00884838101111(21)10110, (01)00884838101111(21)10114, (01)00884838101111(21)10115, (01)00884838101111(21)10117, (01)00884838101111(21)10118, (01)00884838101111(21)10121, (01)00884838101111(21)10122, (01)00884838101111(21)10123, (01)00884838101111(21)10124, (01)00884838101111(21)10129, (01)00884838101111(21)10130, (01)00884838101111(21)10135, (01)00884838101111(21)10139, (01)00884838101111(21)10146, (01)00884838101111(21)10150, (01)00884838101111(21)10153, (01)00884838101111(21)396001, (01)00884838101111(21)396003, (01)00884838101111(21)10170, (01)00884838101111(21)10169, (01)00884838101111(21)10172, (01)00884838101111(21)10177, (01)00884838101111(21)10179, (01)00884838111103(21)397023, (01)00884838101111(21)10176, (01)00884838101111(21)10178, (01)00884838101111(21)10184, (01)00884838101111(21)10183, (01)00884838101111(21)10180, (01)00884838101111(21)10181, (01)00884838101111(21)10185, (01)00884838101111(21)10188, (01)00884838101111(21)10191, (01)00884838101111(21)10190, (01)00884838101111(21)10192, (01)00884838101111(21)10175, (01)00884838101111(21)10189; Serial No. 10148, 10158, 10160, 10162, 10163, 10165, 10166, 10167, 397002, 397003, 397004, 397005, 397006, 397007, 397008, 397009, 397010, 397011, 397013, 397014, 397015, 10021, 10034, 10035, 10036, 10038, 10039, 10042, 10048, 10049, 10052, 10055, 10057, 10067, 10068, 10069, 10081, 10082, 10085, 10087, 10088, 10089, 10091, 10092, 10093, 10096, 10098, 10100, 10102, 10103, 10104, 10105, 10106, 10107, 10108, 10109, 10111, 10112, 10113, 10116, 10119, 10120, 10125, 10126, 10127, 10128, 10131, 10132, 10133, 10134, 10136, 10137, 10138, 10140, 10141, 10142, 10143, 10144, 10145, 10147, 10149, 10151, 10152, 10168, 10171, 397016, 397019, 397018, 397017, 397020, 397021, 10182, 10173, 10174, 397022, 10186, 397024, 397025, 10187, 397027, 397028, 10193, 10155, 10156, 10159, 10161, 10164, 397012, 10013, 10014, 10015, 10016, 10017, 10018, 10019, 10020, 10022, 10023, 10024, 10025, 10031, 10032, 10033, 10040, 10041, 10043, 10044, 10045, 10046, 10047, 10050, 10051, 10053, 10056, 10058, 10059, 10060, 10061, 10062, 10063, 10065, 10066, 10070, 10071, 10072, 10074, 10075, 10076, 10077, 10078, 10079, 10080, 10084, 10086, 10090, 10094, 10095, 10097, 10099, 10101, 10110, 10114, 10115, 10117, 10118, 10121, 10122, 10123, 10124, 10129, 10130, 10135, 10139, 10146, 10150, 10153, 396001, 396003, 10170, 10169, 10172, 10177, 10179, 397023, 10176, 10178, 10184, 10183, 10180, 10181, 10185, 10188, 10191, 10190, 10192, 10175, 10189.

Distribution pattern

Domestic: Nationwide Distribution; Foreign: Australia, Austria, Belgium, China, Czech Republic, Denmark, France, Germany, Israel, Italy, Japan, Malaysia, Netherlands, Norway, Panama, Palestine, Portugal, South Korea, Spain, Switzerland, Thailand, United Kingdom.

Field note

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