FDAFDA · Food and drugs·Recall number Z-0583-2025
Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.
Published December 11, 2024 · Recall initiated: November 16, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential for a plan box not updated issue during Interventional procedure with Spectral CT that may lead to a collision with the operator or with the needle placed inside the patient, and an incorrect patient ID software issue that may lead to misdiagnosis.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips North America Llc
- Distributor
- Worldwide - US Nationwide distribution in the states of AR, AZ, CA, FL, GA, HI, IN, KY, MA, MD, MN, NY, OH, OR, PA, TX, VT, WA, WV and the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, Ecuador, France, Germany, Hong Kong, Israel, Italy, Japan, Jordan, Macao, Malaysia, Netherlands, New Zealand, Norway, Palestine, Panama, Poland, Portugal, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand, United Kingdom, Vietnam.
- Lot
- UDI-DI: (01)00884838101111. Software Version: 5.0.X. Model Number (Serial Numbers): 728333 (10266, 10261, 10264, 10219, 10265, 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, 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, 10210, 10218, 10217, 10206, 10202, 10200, 10211, 10207, 10204, 396004, 10208, 10201, 10205, 10203, 10212, 10213, 10225, 10214, 10220, 10215, 10222, 10227, 10247, 10209, 10226, 10230, 10228, 10232, 10231, 10229, 10221, 10233, 10234, 10235, 10237, 10238, 10223, 10239, 10241, 10242, 10236, 10245, 396005, 10248, 10249, 10243, 10244, 10250, 10259, 10258, 10157, 10262, 10246, 10255, 10254, 10240, 10251, 10256, 10224, 10253, 10257, 10260, 10263), 728340 (397060, 397061, 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, 397036, 397037, 397038, 397034, 397041, 397040, 397039, 397044, 397046, 397043, 397045, 397047, 397048, 397049, 397053, 397050, 397054, 397055, 397056, 397058, 397059), 728344 (397057).
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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