CLASS II ONGOING Device recall · Reported 14 Oct 2026 · FDA Enforcement Report

Spectral CT and Spectral CT 7500 RT recalled by Philips Medical Systems

Philips Medical Systems is recalling Spectral CT and Spectral CT 7500 RT, distributed nationwide in the US. The recall was initiated on 21 Aug 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1. 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;

Quantity recalled539

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0078-2027
FDA event ID: 99796
Recalling firm: Philips Medical Systems, Cambridge, MA
Classification: Class II
Status: Ongoing
Recall initiated: 21 Aug 2026
FDA classified: 2 Oct 2026
Reported: 14 Oct 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

21 Aug 2026	Recall initiated by company
2 Oct 2026	Classified by FDA	+42 days
14 Oct 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.);

Where it was distributed

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.

Nationwide Arkansas Arizona California Colorado Florida Georgia Hawaii Illinois Indiana Kentucky Massachusetts Maryland Minnesota North Carolina New York Ohio Pennsylvania Texas Virginia West Virginia

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

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;

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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