PHILIPS MEDICAL SYSTEMS: 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

Company / brand

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.);

Reason / hazard

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.

Classification

Class II

Status

Ongoing

Distribution / sold at

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.

Recall initiated

2026-08-21

Code info

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;

Product quantity

539

Voluntary mandated

Voluntary: Firm initiated

City

Cambridge

State

MA

Country

United States

Event id

99796

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