Philips North America Llc: Medical Device Recall in 2026 - (Recall #: Z-1317-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2026.

Data Source: FDA.

Product Description:

Spectral CT; Product Code (REF): 728333;

Product Classification:

Class II

Date Initiated: January 7, 2026

Date Posted: February 18, 2026

Recall Number: Z-1317-2026

Event ID: 98248

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.

Status: Ongoing

Product Quantity: 283 units

Code Information:

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,

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated