Recall archive / FDA device enforcement
Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System. — FDA record Z-0725-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 30, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.
- Reason
- Multiple software issues that affect device functionality.
- Classification
- Class II
- Recalling firm
- Philips North America Llc
- Quantity
- 197 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0725-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jan 24, 2024
- Recall initiation date
- Nov 30, 2023
- Center classification date
- Jan 12, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.