Spectral CT and Spectral CT Plus. Model Numbers: 728333… recallZ-0583-2025 · Philips North America Llc · initiated Nov 16, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Philips North America Llc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
Philips notified consignees on about 11/16/2024, via certified mail. Consignees were instructed to identify any affected units on hand, identify if those units contain the affected software version, complete and return the response form, and circulate the Urgent Field Safety Notice Letter to all users of the device. To protect the user and patient from the issue of Plan Box not Updated, remain vigilant and confirm table position during procedures. Press any of the Emergency STOP buttons to stop unintended patient table motion and follow safety instructions in Section 6 of the IFU: Working with Specialized Exams. To avoid the issue of Wrong Patient ID with Anonymous patient, the operator should verify the patient information loaded into the patient data field is correct before scanning and rename the Anonymous record with the patient s name at the time of the scan.
Recall details
- Recall number
- Z-0583-2025
- Status
- Open, Classified
- Initiated by the company
- Nov 16, 2024
- Posted by the FDA
- Dec 3, 2024
- Recalling firm
- Philips North America Llc
- Quantity
- 301 units
- Product code
- JAK
- FDA submissions
- K203020
- Distribution
- 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.
Product description
Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.
Code information (models, lots, serial numbers)
Show the full code information (2k characters)
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).
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Spectral CTPhilips Medical Systems Nederland B.V. · System, x-ray, tomography, computed11 recalls3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page