CLASS II ONGOING Device recall · Reported 18 Feb 2026 · FDA Enforcement Report
Spectral CT; Product recalled by Philips North America
Philips North America is recalling Spectral CT; Product, distributed nationwide in the US. The recall was initiated on 7 Jan 2026 and the FDA has classified it as Class II.
Check your package
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-1317-2026
- FDA event ID
- 98248
- Recalling firm
- Philips North America, Cambridge, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 Jan 2026
- FDA classified
- 6 Feb 2026
- Reported
- 18 Feb 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 7 Jan 2026 | Recall initiated by company | |
| 6 Feb 2026 | Classified by FDA | +30 days |
| 18 Feb 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
As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.
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; Product Code (REF): 728333;
Where it was distributed
Worldwide - US Nationwide distribution in the states of AL, AR, CA, CO, CT, FL, GA, HI, IL, IN, KY, LA, MA, MD, MN, NC, NY, OH, OR, PA, TX, VT, WA, WV and the countries of Australia, Austria, Bahrain, Belgium, Brazil, Bulgaria, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, France, Germany, Hong Kong, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Lithuania, Macao, Mexico, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, R¿union, Russian Fed., Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkmenistan, United Kingdom, Uzbekistan, Vietnam.
Nationwide AlabamaArkansasCaliforniaColoradoConnecticutFloridaGeorgiaHawaiiIllinoisIndianaKentuckyLouisianaMassachusettsMarylandMinnesotaNorth CarolinaNew YorkOhioOregonPennsylvania
Questions about this recall
Is Spectral CT; Product recalled?
Yes. Philips North America recalled Spectral CT; Product on 7 Jan 2026. The recall is Class II and its status is Ongoing. Recall number Z-1317-2026.
Why was it recalled?
As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.
Which lots are affected?
Product Code (REF): 728333; UDI-DI: 00884838101111; Serial Numbers: 10055, 10075, 10086, 10096, 10106, 10116, 10126, 10136, 10146, 10156, 10166, 10176, 10186, 10196, 10206, 10217, 10227, 10237, 10247, 10257, 10267, 10277, 10289, 10302, 10314, 12009, 12019, 12029, 396013, 10056, 10076, 10087, 10097, 10107, 10117, 10127, 10137, 10147, 10157, 10167, 10177, 10187, 10197, 10207, 10218, 10228, 10238, 10248, 10258, 10268, 10278, 10290, 10303, 12000, 12010, 12020, 12030, 398003, 10057, 10077, 10088, 10098, 10108, 10118, 10128, 10138, 10148, 10158, 10168, 10178, 10188, 10198, 10208, 10219, 10229, 10239, 10249, 10259, 10269, 10279, 10291, 10304, 12001, 12011, 12021, 12031, 398004, 10058, 10078, 10089, 10099, 10109, 10119, 10129, 10139, 10149, 10159, 10169, 10179, 10189, 10199, 10209, 10220, 10230, 10240, 10250, 10260, 10270, 10280, 10292, 10305, 12002, 12012, 12022, 396005, 10059, 10079, 10090, 10100, 10110, 10120, 10130, 10140, 10150, 10160, 10170, 10180, 10190, 10200, 10210, 10221, 10231, 10241, 10251, 10261, 10271, 10281, 10293, 10306, 12003, 12013, 12023, 396006, 10060, 10080, 10091, 10101, 10111, 10121, 10131, 10141, 10151, 10161, 10171, 10181, 10191, 10201, 10211, 10222, 10232, 10242, 10252, 10262, 10272, 10284, 10294, 10307, 12004, 12014, 12024, 396008, 10061, 10081, 10092, 10102, 10112, 10122, 10132, 10142, 10152, 10162, 10172, 10182, 10192, 10202, 10212, 10223, 10233, 10243, 10253, 10263, 10273, 10285, 10298, 10308, 12005, 12015, 12025, 396009, 10062, 10082, 10093, 10103, 10113, 10123, 10133, 10143, 10153, 10163, 10173, 10183, 10193, 10203, 10213, 10224, 10234, 10244, 10254, 10264, 10274, 10286, 10299, 10310, 12006, 12016, 12026, 396010, 10070, 10083, 10094, 10104, 10114, 10124, 10134, 10144, 10154, 10164, 10174, 10184, 10194, 10204, 10214, 10225, 10235, 10245, 10255, 10265, 10275, 10287, 10300, 10311, 12007, 12017, 12027, 396011, 10074, 10085, 10095, 10105, 10115, 10125, 10135, 10145, 10155, 10165, 10175, 10185, 10195, 10205, 10215, 10226, 10236, 10246, 10256, 10266, 10276, 10288, 10301, 10312, 12008, 12018, 12028, 396012,
Where was it sold?
Worldwide - US Nationwide distribution in the states of AL, AR, CA, CO, CT, FL, GA, HI, IL, IN, KY, LA, MA, MD, MN, NC, NY, OH, OR, PA, TX, VT, WA, WV and the countries of Australia, Austria, Bahrain, Belgium, Brazil, Bulgaria, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, France, Germany, Hong Kong, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Lithuania, Macao, Mexico, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, R¿union, Russian Fed., Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkmenistan, United Kingdom, Uzbekistan, Vietnam.
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 Sep 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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