Fresh Recalls

FDAClass II · Medical device · Recall Z-0078-2027 · Recalled October 14, 2026

Spectral CT and Spectral CT 7500 RT recall — PHILIPS MEDICAL SYSTEMS

Agency report date: October 14, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named
Spectral CT and Spectral CT 7500 RT
Company / brand
PHILIPS MEDICAL SYSTEMS
Lot / serial / date codes
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;
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.
Agency product description and boundaries

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.);

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: 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.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: Spectral CT and Spectral CT 7500 RT recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID
Z-0078-2027
Brand
All PHILIPS MEDICAL SYSTEMS recalls
Classification
Class II
Units affected
539
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Affected products

Companies & origin

Recalling firm location
Cambridge, MA, United States
Firm address
222 Jacobs St, N/A, 02141-2289

Identifying details (verbatim from the notice)

Product codes / 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;
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.
Firm notified the public via
Letter
FDA event ID
99796
Recall initiated
August 21, 2026
FDA classified
October 2, 2026
FDA report date
October 14, 2026

Other medical device recalls from around the same time

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 12:00 PM UTC. Record retrieved October 22, 2026 at 12:00 PM UTC.

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