510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-0078-2027

Spectral CT and Spectral CT 7500 RT; Software Version Numbers: 5.2.X (U.S.); 5.0.X, 5.2.X, 5.4.X (Outside...

Philips Medical Systems / initiated 2026-08-21 / Open, Classified
FDA source (opens on fda.gov)

Recall record

Recall number
Z-0078-2027
Status
Open, Classified
Initiated
Posted
Recalling firm
Philips Medical Systems
Product
Spectral CT and Spectral CT 7500 RT; Software Version Numbers: 5.2.X (U.S.); 5.0.X, 5.2.X, 5.4.X (Outside U.S.); Model Numbers: 1. 728333 (U.S. and Outside U.S.), 2. 728340 (Outside U.S.), 3. 728344 (Outside U.S.), 4. 728345 (Outside U.S.);
Product code
JAK System, X-Ray, Tomography, Computed
Reason for recall
Software issues may affect the safety and performance of Spectral CT system(s). The issues may result in image artifacts, wrong slice thickness, or unintended system motion.
FDA root cause
Under Investigation by firm
Action
On August 21, 2026, URGENT Medical Device Correction letters were sent to customers. Customer actions: User Instructions Philips recommends the following actions be taken for continued safe use of the device: 1. Continue to use your system(s) in accordance with the intended use; 2. Circulate this notice to all users of the device so that they are aware of the product issues, associated potential hazards, and manufacturer recommendations (refer to Table 1 and Table 2 for specific details regarding recommended actions); 3. Post this notice near the affected unit(s) for ease of reference until a solution is installed on your system. 4. Please complete and return the attached response form within 30 days to confirm receipt and understanding of this notice.
Quantity in commerce
539
Distribution
Worldwide - US Nationwide distribution in the states of AR, AZ, CA, CO, FL, GA, HI, IL, IN, KY, MA, MD, MN, NC, NY, OH, PA, TX, VA, WV and the countries of Australia, Austria, Belgium, Bulgaria, China, Croatia, Czech Republic, Denmark, Ecuador, El Salvador, France, Germany, Hong Kong, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lithuania, Macao, Malaysia, Mexico, Monaco, Netherlands, New Zealand, Nicaragua, Norway, Palestine, Panama, Philippines, Poland, Portugal, Romania, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand, United Kingdom, Vietnam.
Product codes and lots
1. Model Number: 728333 (U.S.); UDI-DI: 1. 00884838101111, 2. 00884838127876; Serial Numbers: 12055, 12054, 12052, 398006, 12044, 12045, 10237, 10056, 10194, 12059, 10278, 10319, 10143, 10081, 12047, 12048, 10198, 12046, 12043, 10262, 12042, 12041, 10186, 10241, 12039, 10317, 10316, 10264, 10127, 12038, 12037, 396014, 12036, 398005, 10016, 12034, 10076, 10074, 12035, 10021, 10018, 10023, 12032, 12029, 398003, 398004, 396013, 12027, 12026, 12023, 12025, 12024, 12021, 12022, 12017, 12019, 12018, 12020, 10312, 10311, 10310, 10305, 12016, 10308, 10306, 10307, 12014, 12013, 10304, 10302, 12012, 12011, 12010, 396012, 12007, 10301, 12009, 10300, 10299, 12008, 12006, 12005, 10298, 12002, 12003, 10294, 10292, 12001, 12000, 10293, 10290, 396011, 396010, 10291, 10289, 10279, 10288, 10287, 10284, 10286, 10281, 10285, 10271, 10276, 396009, 10280, 10275, 10273, 10277, 396008, 396006, 396007, 10274, 10272, 10270, 10269, 10252, 10154, 10268, 10267, 10261, 10266, 10265, 10219, 10263, 10260, 10157, 10259, 10224, 10240, 10257, 10246, 10258, 10253, 10256, 10251, 10254, 10243, 10250, 10248, 10247, 10244, 10249, 10245, 10236, 10223, 10239, 10242, 10235, 10234, 10221, 10231, 10209, 10232, 10228, 10226, 10229, 10230, 10220, 10217, 10227, 10225, 10218, 10222, 10212, 10214, 10215, 10213, 10211, 10210, 396004, 10208, 10207, 10206, 10204, 10202, 10197, 10203, 10205, 10200, 10201, 10199, 10196, 10195, 10193, 10175, 10190, 10189, 10188, 10191, 10187, 10184, 10185, 10183, 10181, 10180, 10182, 10179, 10178, 10177, 10174, 10176, 10173, 10172, 10171, 10170, 10168, 10169, 10167, 10163, 10165, 10166, 10158, 10161, 10160, 10148, 10159, 10156, 10155, 10153, 10152, 10150, 10151, 10149, 10147, 10146, 10145, 10144, 10141, 10142, 10140, 10138, 10139, 10137, 10134, 10136, 10135, 10133, 10132, 10130, 10131, 10128, 10129, 10126, 10049, 10124, 10119, 10123, 10121, 10120, 10118, 10122, 10032, 10116, 10113, 10115, 10114, 10111, 10112, 10110, 10104, 396003, 396001, 10109, 10108, 10107, 10106, 10105, 10097, 10103, 10100, 10102, 10101, 10098, 10099, 10090, 10096, 10095, 10093, 10094, 10091, 10086, 10088, 10085, 10089, 10087, 10084, 10082, 10080, 10077, 10078, 10075, 10069, 10072, 10071, 10070, 10067, 10068, 10066, 10065, 10062, 10061, 10060, 10057, 10058, 10052, 10055, 10053, 10050, 10047, 10045, 10048, 10044, 10042, 10043, 10041, 10040, 10039, 10038, 10036, 10035, 10034, 10031, 10033, 10027, 10024, 10020, 10019, 10017, 10015, 10013, 10117, 10079, 10314, 12028, 12015, 10303, 10233, 10162, 12033, 12031, 12030, 10092, 10046, 10125, 10063, 10025; 2. Model Number: 728340 (Outside U.S.); UDI-DI: 00884838111103; Serial Numbers: 397035, 397004, 397168, 397167, 397164, 397159, 397160, 397155, 397153, 397152, 397150, 397151, 397148, 397147, 397146, 397145, 397141, 397142, 397139, 397140, 397137, 397133, 397132, 397130, 397126, 397125, 397123, 397121, 397120, 397117, 397116, 397115, 397112, 397110, 397108, 397107, 397106, 397102, 397101, 397099, 397098, 397096, 397095, 397093, 397091, 397085, 397089, 397088, 397087, 397086, 397084, 397083, 397082, 397080, 397081, 397079, 397077, 397076, 397075, 397073, 397072, 397071, 397070, 397067, 397066, 397065, 397062, 397064, 397063, 397060, 397061, 397059, 397058, 397056, 397055, 397054, 397053, 397050, 397049, 397047, 397048, 397046, 397045, 397043, 397044, 397041, 397040, 397039, 397038, 397037, 397036, 397034, 397033, 397032, 397026, 397031, 397029, 397028, 397027, 397025, 397024, 397023, 397022, 397021, 397020, 397018, 397019, 397016, 397017, 397015, 397014, 397012, 397009, 397013, 397011, 397003, 397010, 397008, 397006, 397002, 397005, 397007, 397105, 397030, 397128, 397119, 397097; 3. Model Number: 728344 (Outside U.S.); UDI-DI: 00884838117822; Serial Numbers: 397170, 397162, 397158, 397149, 397166, 397165, 397163, 397161, 397156, 397143, 397136, 397135, 397131, 397129, 397127, 397122, 397124, 397118, 397114, 397113, 397111, 397104, 397100, 397094, 397092, 397090, 397078, 397074, 397068, 397057, 397103; 4. Model Number: 728345 (Outside U.S.); UDI-DI: 00884838123748; Serial Numbers: 14004, 399003, 14001, 14000;