Spectral CT; Product Code (REF): 728333;
Publicado el 18 de febrero de 2026 · Inicio del retiro: 7 de enero de 2026
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Philips North America Llc
- Distribuidor
- 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.
- Lote
- 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,
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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