Z-0583-2025Class II

Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344

Name: Z-0583-2025 Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344
Creator: Philips North America Llc
Published: 2024-11-16
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2024-11-16 / Open, Classified / root cause: software

FDA source

Philips North America Llc began a recall of Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344 on 2024-11-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0583-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-11-16
Posted: 2024-12-03
Recalling firm: Philips North America LLC
Product: Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: 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.
Root cause tag: software
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 301 units
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 codes and lots: 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).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0583-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0583-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-03

Product code JAK

K203020Class IISpectral CTPhilips Medical Systems Nederland B.V. / cleared 2021-02-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)