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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93798

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

Open FDA event record

Event summary

Timeline bucket
December 13, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
PHILIPS MEDICAL SYSTEMS

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

2 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 2

Spectral CT on Rails: Software Version 5.1.0.X, model 728334.

Z-1054-2024
Recall number
Z-1054-2024
Initiated
December 13, 2023
Classification
Class II
Status
Ongoing
Recalling firm
PHILIPS MEDICAL SYSTEMS
Quantity
US: 1

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software issue

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

A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.

Code information

UDI-DI: 00884838103627, serial number: 1005.

Distribution pattern

Worldwide - US Nationwide distribution in the states of AR, AZ, GA, HI, IN, KY, MA, MD, MN, NY, OH, PA, TX & WV; the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, Germany, Israel, Italy, Japan, Macao, Malaysia, Netherlands, Norway, Palestine, Panama, Portugal, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand & United Kingdom.

device · product 2 of 2

Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 China: Software Version 5.0, Model 728340.

Z-1055-2024
Recall number
Z-1055-2024
Initiated
December 13, 2023
Classification
Class II
Status
Ongoing
Recalling firm
PHILIPS MEDICAL SYSTEMS
Quantity
US: 33, OUS 177

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software issue

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

A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.

Code information

UDI-DI: 00884838101111, Model 728333, serial numbers: 10197, 10182, 10175, 10192, 10179, 10196, 10180, 10188, 10190, 10181, 10183, 10178, 10186, 10185, 10199, 10184, 10198, 10193, 10187, 10189, 10195, 10191, 10194, 10018, 10023, 10027, 10062, 10072, 10078, 10079, 10080, 10084, 10088, 10101, 10104, 10112, 10117, 10113, 10116, 10032, 10049, 10133, 10140, 10152, 10153, 10166, 10170, 10171, 10173, 10172, 10174, 10016, 10015, 10017, 10019, 10022, 10021, 10020, 10025, 10024, 10033, 10031, 10034, 10035, 10036, 10038, 10039, 10040, 10041, 10043, 10042, 10014, 10044, 10046, 10048, 10045, 10047, 10051, 10050, 10053, 10055, 10052, 10056, 10058, 10057, 10059, 10060, 10061, 10065, 10066, 10068, 10067, 10070, 10071, 10063, 10069, 10074, 10075, 10077, 10076, 10081, 10082, 10087, 10089, 10085, 10086, 10091, 10092, 10094, 10093, 10095, 10096, 10090, 10099, 10098, 10102, 10100, 10103, 10097, 10105, 10106, 10107, 10108, 10109, 396001, 396003, 10110, 10111, 10114, 10115, 10122, 10118, 10120, 10121, 10123, 10119, 10124, 10125, 10126, 10127, 10129, 10128, 10131, 10130, 10132, 10135, 10136, 10134, 10137, 10139, 10138, 10142, 10141, 10143, 10144, 10145, 10146, 10147, 10149, 10150, 10151, 10155, 10156, 10159, 10148, 10160, 10161, 10162, 10158, 10164, 10163, 10165, 10167, 10168, 10169, 10013, 10177, 10176. Model: 728340, serial numbers: 397022, 397023, 397020, 397024, 397021, 397025, 397027, 397031, 397026, 397033, 397032, 397030, 397028, 397029, 397015, 397016, 397004, 397007, 397005, 397002, 397006, 397008, 397010, 397003, 397011, 397013, 397009, 397012, 397014, 397017, 397019, 397018. .

Distribution pattern

Worldwide - US Nationwide distribution in the states of AR, AZ, GA, HI, IN, KY, MA, MD, MN, NY, OH, PA, TX & WV; the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, Germany, Israel, Italy, Japan, Macao, Malaysia, Netherlands, Norway, Palestine, Panama, Portugal, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand & United Kingdom.