Recall archive / FDA device enforcement
Spectral CT. Computed tomography X-ray system. — FDA record Z-2034-2025
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 May 29, 2025. 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. Computed tomography X-ray system.
- Reason
- Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional software issues that affect CT performance.
- Classification
- Class II
- Recalling firm
- Philips North America Llc
- Quantity
- 370 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2034-2025
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 | Part No. 728333; UDI: (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)10021, (01)00884838101111(21)10022, (01)00884838101111(21)10023, (01)00884838101111(21)10024, (01)00884838101111(21)10025, (01)00884838101111(21)10027, (01)00884838101111(21)10031, (01)00884838101111(21)10032, (01)00884838101111(21)10033, (01)00884838101111(21)10034, (01)00884838101111(21)10035, (01)00884838101111(21)10036, (01)00884838101111(21)10038, (01)00884838101111(21)10039, (01)00884838101111(21)10040, (01)00884838101111(21)10041, (01)00884838101111(21)10042, (01)00884838101111(21)10043, (01)00884838101111(21)10044, (01)00884838101111(21)10045, (01)00884838101111(21)10046, (01)00884838101111(21)10047, (01)00884838101111(21)10048, (01)00884838101111(21)10049, (01)00884838101111(21)10050, (01)00884838101111(21)10052, (01)00884838101111(21)10053, (01)00884838101111(21)10055, (01)00884838101111(21)10056, (01)00884838101111(21)10057, (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)10067, (01)00884838101111(21)10068, (01)00884838101111(21)10069, (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)10081, (01)00884838101111(21)10082, (01)00884838101111(21)10084, (01)00884838101111(21)10085, (01)00884838101111(21)10086, (01)00884838101111(21)10087, (01)00884838101111(21)10088, (01)00884838101111(21)10089, (01)00884838101111(21)10090, (01)00884838101111(21)10091, (01)00884838101111(21)10092, (01)00884838101111(21)10093, (01)00884838101111(21)10094, (01)00884838101111(21)10095, (01)00884838101111(21)10096, (01)00884838101111(21)10097, (01)00884838101111(21)10098, (01)00884838101111(21)10099, (01)00884838101111(21)10100, (01)00884838101111(21)10101, (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)10110, (01)00884838101111(21)10111, (01)00884838101111(21)10112, (01)00884838101111(21)10113, (01)00884838101111(21)10114, (01)00884838101111(21)10115, (01)00884838101111(21)10116, (01)00884838101111(21)10117, (01)00884838101111(21)10118, (01)00884838101111(21)10119, (01)00884838101111(21)10120, (01)00884838101111(21)10121, (01)00884838101111(21)10122, (01)00884838101111(21)10123, (01)00884838101111(21)10124, (01)00884838101111(21)10125, (01)00884838101111(21)10126, (01)00884838101111(21)10127, (01)00884838101111(21)10128, (01)00884838101111(21)10129, (01)00884838101111(21)10130, (01)00884838101111(21)10131, (01)00884838101111(21)10132, (01)00884838101111(21)10133, (01)00884838101111(21)10134, (01)00884838101111(21)10135, (01)00884838101111(21)10136, (01)00884838101111(21)10137, (01)00884838101111(21)10138, (01)00884838101111(21)10139, (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)10146, (01)00884838101111(21)10147, (01)00884838101111(21)10148, (01)00884838101111(21)10149, (01)00884838101111(21)10150, (01)00884838101111(21)10151, (01)00884838101111(21)10152, (01)00884838101111(21)10153, (01)00884838101111(21)10154, (01)00884838101111(21)10155, (01)00884838101111(21)10156, (01)00884838101111(21)10157, (01)00884838101111(21)10158, (01)00884838101111(21)10159, (01)00884838101111(21)10160, (01)00884838101111(21)10161, (01)00884838101111(21)10162, (01)00884838101111(21)10163, (01)00884838101111(21)10164, (01)00884838101111(21)10165, (01)00884838101111(21)10166, (01)00884838101111(21)10167, (01)00884838101111(21)10168, (01)00884838101111(21)10169, (01)00884838101111(21)10170, (01)00884838101111(21)10171, (01)00884838101111(21)10172, (01)00884838101111(21)10173, (01)00884838101111(21)10174, (01)00884838101111(21)10175, (01)00884838101111(21)10176, (01)00884838101111(21)10177, (01)00884838101111(21)10178, (01)00884838101111(21)10179, (01)00884838101111(21)10180, (01)00884838101111(21)10181, (01)00884838101111(21)10182, (01)00884838101111(21)10183, (01)00884838101111(21)10184, (01)00884838101111(21)10185, (01)00884838101111(21)10186, (01)00884838101111(21)10187, (01)00884838101111(21)10188, (01)00884838101111(21)10189, (01)00884838101111(21)10190, (01)00884838101111(21)10191, (01)00884838101111(21)10192, (01)00884838101111(21)10193, (01)00884838101111(21)10194, (01)00884838101111(21)10195, (01)00884838101111(21)10196, (01)00884838101111(21)10197, (01)00884838101111(21)10198, (01)00884838101111(21)10199, (01)00884838101111(21)10200, (01)00884838101111(21)10201, (01)00884838101111(21)10202, (01)00884838101111(21)10203, (01)00884838101111(21)10204, (01)00884838101111(21)10205, (01)00884838101111(21)10206, (01)00884838101111(21)10207, (01)00884838101111(21)10208, (01)00884838101111(21)10209, (01)00884838101111(21)10210, (01)00884838101111(21)10211, (01)00884838101111(21)10212, (01)00884838101111(21)10213, (01)00884838101111(21)10214, (01)00884838101111(21)10215, (01)00884838101111(21)10217, (01)00884838101111(21)10218, (01)00884838101111(21)10219, (01)00884838101111(21)10220, (01)00884838101111(21)10221, (01)00884838101111(21)10222, (01)00884838101111(21)10223, (01)00884838101111(21)10224, (01)00884838101111(21)10225, (01)00884838101111(21)10226, (01)00884838101111(21)10227, (01)00884838101111(21)10228, (01)00884838101111(21)10229, (01)00884838101111(21)10230, (01)00884838101111(21)10231, (01)00884838101111(21)10232, (01)00884838101111(21)10233, (01)00884838101111(21)10234, (01)00884838101111(21)10235, (01)00884838101111(21)10236, (01)00884838101111(21)10237, (01)00884838101111(21)10238, (01)00884838101111(21)10239, (01)00884838101111(21)10240, (01)00884838101111(21)10241, (01)00884838101111(21)10242, (01)00884838101111(21)10243, (01)00884838101111(21)10244, (01)00884838101111(21)10245, (01)00884838101111(21)10246, (01)00884838101111(21)10247, (01)00884838101111(21)10248, (01)00884838101111(21)10249, (01)00884838101111(21)10250, (01)00884838101111(21)10251, (01)00884838101111(21)10252, (01)00884838101111(21)10253, (01)00884838101111(21)10254, (01)00884838101111(21)10255, (01)00884838101111(21)10256, (01)00884838101111(21)10257, (01)00884838101111(21)10258, (01)00884838101111(21)10259, (01)00884838101111(21)10260, (01)00884838101111(21)10261, (01)00884838101111(21)10262, (01)00884838101111(21)10263, (01)00884838101111(21)10264, (01)00884838101111(21)10265, (01)00884838101111(21)10266, (01)00884838101111(21)10267, (01)00884838101111(21)10268, (01)00884838101111(21)10269, (01)00884838101111(21)10270, (01)00884838101111(21)10271, (01)00884838101111(21)10272, (01)00884838101111(21)10273, (01)00884838101111(21)10274, (01)00884838101111(21)10275, (01)00884838101111(21)10276, (01)00884838101111(21)10277, (01)00884838101111(21)10278, (01)00884838101111(21)10279, (01)00884838101111(21)10280, (01)00884838101111(21)10281, (01)00884838101111(21)10284, (01)00884838101111(21)10285, (01)00884838101111(21)10286, (01)00884838101111(21)10287, (01)00884838101111(21)10288, (01)00884838101111(21)10289, (01)00884838101111(21)10290, (01)00884838101111(21)10291, (01)00884838101111(21)10292, (01)00884838101111(21)10293, (01)00884838101111(21)10294, (01)00884838101111(21)10298, (01)00884838101111(21)10299, (01)00884838101111(21)10300, (01)00884838101111(21)10301, (01)00884838101111(21)12000, (01)00884838101111(21)12001, (01)00884838101111(21)12002, (01)00884838101111(21)12003, (01)00884838101111(21)12004, (01)00884838101111(21)12005, (01)00884838101111(21)12006, (01)00884838101111(21)12007, (01)00884838101111(21)12008, (01)00884838101111(21)12009, (01)00884838101111(21)396001, (01)00884838101111(21)396003, (01)00884838101111(21)396004, (01)00884838101111(21)396005, (01)00884838101111(21)396006, (01)00884838101111(21)396007, (01)00884838101111(21)396008, (01)00884838101111(21)396009, (01)00884838101111(21)396010, (01)00884838101111(21)396011; Serial No. 10013, 10014, 10015, 10016, 10017, 10018, 10019, 10020, 10021, 10022, 10023, 10024, 10025, 10027, 10031, 10032, 10033, 10034, 10035, 10036, 10038, 10039, 10040, 10041, 10042, 10043, 10044, 10045, 10046, 10047, 10048, 10049, 10050, 10052, 10053, 10055, 10056, 10057, 10058, 10059, 10060, 10061, 10062, 10063, 10065, 10066, 10067, 10068, 10069, 10070, 10071, 10072, 10074, 10075, 10076, 10077, 10078, 10079, 10080, 10081, 10082, 10084, 10085, 10086, 10087, 10088, 10089, 10090, 10091, 10092, 10093, 10094, 10095, 10096, 10097, 10098, 10099, 10100, 10101, 10102, 10103, 10104, 10105, 10106, 10107, 10108, 10109, 10110, 10111, 10112, 10113, 10114, 10115, 10116, 10117, 10118, 10119, 10120, 10121, 10122, 10123, 10124, 10125, 10126, 10127, 10128, 10129, 10130, 10131, 10132, 10133, 10134, 10135, 10136, 10137, 10138, 10139, 10140, 10141, 10142, 10143, 10144, 10145, 10146, 10147, 10148, 10149, 10150, 10151, 10152, 10153, 10154, 10155, 10156, 10157, 10158, 10159, 10160, 10161, 10162, 10163, 10164, 10165, 10166, 10167, 10168, 10169, 10170, 10171, 10172, 10173, 10174, 10175, 10176, 10177, 10178, 10179, 10180, 10181, 10182, 10183, 10184, 10185, 10186, 10187, 10188, 10189, 10190, 10191, 10192, 10193, 10194, 10195, 10196, 10197, 10198, 10199, 10200, 10201, 10202, 10203, 10204, 10205, 10206, 10207, 10208, 10209, 10210, 10211, 10212, 10213, 10214, 10215, 10217, 10218, 10219, 10220, 10221, 10222, 10223, 10224, 10225, 10226, 10227, 10228, 10229, 10230, 10231, 10232, 10233, 10234, 10235, 10236, 10237, 10238, 10239, 10240, 10241, 10242, 10243, 10244, 10245, 10246, 10247, 10248, 10249, 10250, 10251, 10252, 10253, 10254, 10255, 10256, 10257, 10258, 10259, 10260, 10261, 10262, 10263, 10264, 10265, 10266, 10267, 10268, 10269, 10270, 10271, 10272, 10273, 10274, 10275, 10276, 10277, 10278, 10279, 10280, 10281, 10284, 10285, 10286, 10287, 10288, 10289, 10290, 10291, 10292, 10293, 10294, 10298, 10299, 10300, 10301, 12000, 12001, 12002, 12003, 12004, 12005, 12006, 12007, 12008, 12009, 396001, 396003, 396004, 396005, 396006, 396007, 396008, 396009, 396010, 396011. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Domestic: AZ, CA, CO, FL, GA, HI, IN, KY, MA, MD, MN, NY, OH, OR, PA, TX, VT, WA, WV; Foreign: Australia, Austria, Belgium, China, Czech Republic, Denmark, Ecuador, France, Germany, Hong Kong, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Lithuania, Macao, Malaysia, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand, United Kingdom, Vietnam.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jul 2, 2025
- Recall initiation date
- May 29, 2025
- Center classification date
- Jun 26, 2025
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.