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RecallWatchMedical Device Safety
Class IIOngoingZ-2034-2025

Philips North America LLC recalls Spectral CT. Computed tomography X-ray system.

Philips North America LlcCambridge, MA, United StatesReported Jul 2, 2025 · 1 year ago
Legal News Analyst ·

Reason for recall

Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional software issues that affect CT performance.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Spectral CT. Computed tomography X-ray system.

Lot / code information

Part / Item #
728333
UDI
(01)00884838101111(21)10014, (01)00884838101111(21)10015, (01)00884838101111(21)10016, (01)00884838101111(21)10017, (01)00884838101111(21)10018, (01)00884838101111(21)10019 — +286 moreShow all
(01)00884838101111(21)10014, (01)00884838101111(21)10015, (01)00884838101111(21)10016, (01)00884838101111(21)10017, (01)00884838101111(21)10018, (01)00884838101111(21)10019, (01)00884838101111(21)10020, (01)00884838101111(21)10021, (01)00884838101111(21)10022, (01)00884838101111(21)10023, (01)00884838101111(21)10024, (01)00884838101111(21)10025, (01)00884838101111(21)10027, (01)00884838101111(21)10031, (01)00884838101111(21)10032, (01)00884838101111(21)10033, (01)00884838101111(21)10034, (01)00884838101111(21)10035, (01)00884838101111(21)10036, (01)00884838101111(21)10038, (01)00884838101111(21)10039, (01)00884838101111(21)10040, (01)00884838101111(21)10041, (01)00884838101111(21)10042, (01)00884838101111(21)10043, (01)00884838101111(21)10044, (01)00884838101111(21)10045, (01)00884838101111(21)10046, (01)00884838101111(21)10047, (01)00884838101111(21)10048, (01)00884838101111(21)10049, (01)00884838101111(21)10050, (01)00884838101111(21)10052, (01)00884838101111(21)10053, (01)00884838101111(21)10055, (01)00884838101111(21)10056, (01)00884838101111(21)10057, (01)00884838101111(21)10058, (01)00884838101111(21)10059, (01)00884838101111(21)10060, (01)00884838101111(21)10061, (01)00884838101111(21)10062, (01)00884838101111(21)10063, (01)00884838101111(21)10065, (01)00884838101111(21)10066, (01)00884838101111(21)10067, (01)00884838101111(21)10068, (01)00884838101111(21)10069, (01)00884838101111(21)10070, (01)00884838101111(21)10071, (01)00884838101111(21)10072, (01)00884838101111(21)10074, (01)00884838101111(21)10075, (01)00884838101111(21)10076, (01)00884838101111(21)10077, (01)00884838101111(21)10078, (01)00884838101111(21)10079, (01)00884838101111(21)10080, (01)00884838101111(21)10081, (01)00884838101111(21)10082, (01)00884838101111(21)10084, (01)00884838101111(21)10085, (01)00884838101111(21)10086, (01)00884838101111(21)10087, (01)00884838101111(21)10088, (01)00884838101111(21)10089, (01)00884838101111(21)10090, (01)00884838101111(21)10091, (01)00884838101111(21)10092, (01)00884838101111(21)10093, (01)00884838101111(21)10094, (01)00884838101111(21)10095, (01)00884838101111(21)10096, (01)00884838101111(21)10097, (01)00884838101111(21)10098, (01)00884838101111(21)10099, (01)00884838101111(21)10100, (01)00884838101111(21)10101, (01)00884838101111(21)10102, (01)00884838101111(21)10103, (01)00884838101111(21)10104, (01)00884838101111(21)10105, (01)00884838101111(21)10106, (01)00884838101111(21)10107, (01)00884838101111(21)10108, (01)00884838101111(21)10109, (01)00884838101111(21)10110, (01)00884838101111(21)10111, (01)00884838101111(21)10112, (01)00884838101111(21)10113, (01)00884838101111(21)10114, (01)00884838101111(21)10115, (01)00884838101111(21)10116, (01)00884838101111(21)10117, (01)00884838101111(21)10118, (01)00884838101111(21)10119, (01)00884838101111(21)10120, (01)00884838101111(21)10121, (01)00884838101111(21)10122, (01)00884838101111(21)10123, (01)00884838101111(21)10124, (01)00884838101111(21)10125, (01)00884838101111(21)10126, (01)00884838101111(21)10127, (01)00884838101111(21)10128, (01)00884838101111(21)10129, (01)00884838101111(21)10130, (01)00884838101111(21)10131, (01)00884838101111(21)10132, (01)00884838101111(21)10133, (01)00884838101111(21)10134, (01)00884838101111(21)10135, (01)00884838101111(21)10136, (01)00884838101111(21)10137, (01)00884838101111(21)10138, (01)00884838101111(21)10139, (01)00884838101111(21)10140, (01)00884838101111(21)10141, (01)00884838101111(21)10142, (01)00884838101111(21)10143, (01)00884838101111(21)10144, (01)00884838101111(21)10145, (01)00884838101111(21)10146, (01)00884838101111(21)10147, (01)00884838101111(21)10148, (01)00884838101111(21)10149, (01)00884838101111(21)10150, (01)00884838101111(21)10151, (01)00884838101111(21)10152, (01)00884838101111(21)10153, (01)00884838101111(21)10154, (01)00884838101111(21)10155, (01)00884838101111(21)10156, (01)00884838101111(21)10157, (01)00884838101111(21)10158, (01)00884838101111(21)10159, (01)00884838101111(21)10160, (01)00884838101111(21)10161, (01)00884838101111(21)10162, (01)00884838101111(21)10163, (01)00884838101111(21)10164, (01)00884838101111(21)10165, (01)00884838101111(21)10166, (01)00884838101111(21)10167, (01)00884838101111(21)10168, (01)00884838101111(21)10169, (01)00884838101111(21)10170, (01)00884838101111(21)10171, (01)00884838101111(21)10172, (01)00884838101111(21)10173, (01)00884838101111(21)10174, (01)00884838101111(21)10175, (01)00884838101111(21)10176, (01)00884838101111(21)10177, (01)00884838101111(21)10178, (01)00884838101111(21)10179, (01)00884838101111(21)10180, (01)00884838101111(21)10181, (01)00884838101111(21)10182, (01)00884838101111(21)10183, (01)00884838101111(21)10184, (01)00884838101111(21)10185, (01)00884838101111(21)10186, (01)00884838101111(21)10187, (01)00884838101111(21)10188, (01)00884838101111(21)10189, (01)00884838101111(21)10190, (01)00884838101111(21)10191, (01)00884838101111(21)10192, (01)00884838101111(21)10193, (01)00884838101111(21)10194, (01)00884838101111(21)10195, (01)00884838101111(21)10196, (01)00884838101111(21)10197, (01)00884838101111(21)10198, (01)00884838101111(21)10199, (01)00884838101111(21)10200, (01)00884838101111(21)10201, (01)00884838101111(21)10202, (01)00884838101111(21)10203, (01)00884838101111(21)10204, (01)00884838101111(21)10205, (01)00884838101111(21)10206, (01)00884838101111(21)10207, (01)00884838101111(21)10208, (01)00884838101111(21)10209, (01)00884838101111(21)10210, (01)00884838101111(21)10211, (01)00884838101111(21)10212, (01)00884838101111(21)10213, (01)00884838101111(21)10214, (01)00884838101111(21)10215, (01)00884838101111(21)10217, (01)00884838101111(21)10218, (01)00884838101111(21)10219, (01)00884838101111(21)10220, (01)00884838101111(21)10221, (01)00884838101111(21)10222, (01)00884838101111(21)10223, (01)00884838101111(21)10224, (01)00884838101111(21)10225, (01)00884838101111(21)10226, (01)00884838101111(21)10227, (01)00884838101111(21)10228, (01)00884838101111(21)10229, (01)00884838101111(21)10230, (01)00884838101111(21)1023 …
Serial #
10013, 10014, 10015, 10016, 10017, 10018 — +287 moreShow all
10013, 10014, 10015, 10016, 10017, 10018, 10019, 10020, 10021, 10022, 10023, 10024, 10025, 10027, 10031, 10032, 10033, 10034, 10035, 10036, 10038, 10039, 10040, 10041, 10042, 10043, 10044, 10045, 10046, 10047, 10048, 10049, 10050, 10052, 10053, 10055, 10056, 10057, 10058, 10059, 10060, 10061, 10062, 10063, 10065, 10066, 10067, 10068, 10069, 10070, 10071, 10072, 10074, 10075, 10076, 10077, 10078, 10079, 10080, 10081, 10082, 10084, 10085, 10086, 10087, 10088, 10089, 10090, 10091, 10092, 10093, 10094, 10095, 10096, 10097, 10098, 10099, 10100, 10101, 10102, 10103, 10104, 10105, 10106, 10107, 10108, 10109, 10110, 10111, 10112, 10113, 10114, 10115, 10116, 10117, 10118, 10119, 10120, 10121, 10122, 10123, 10124, 10125, 10126, 10127, 10128, 10129, 10130, 10131, 10132, 10133, 10134, 10135, 10136, 10137, 10138, 10139, 10140, 10141, 10142, 10143, 10144, 10145, 10146, 10147, 10148, 10149, 10150, 10151, 10152, 10153, 10154, 10155, 10156, 10157, 10158, 10159, 10160, 10161, 10162, 10163, 10164, 10165, 10166, 10167, 10168, 10169, 10170, 10171, 10172, 10173, 10174, 10175, 10176, 10177, 10178, 10179, 10180, 10181, 10182, 10183, 10184, 10185, 10186, 10187, 10188, 10189, 10190, 10191, 10192, 10193, 10194, 10195, 10196, 10197, 10198, 10199, 10200, 10201, 10202, 10203, 10204, 10205, 10206, 10207, 10208, 10209, 10210, 10211, 10212, 10213, 10214, 10215, 10217, 10218, 10219, 10220, 10221, 10222, 10223, 10224, 10225, 10226, 10227, 10228, 10229, 10230, 10231, 10232, 10233, 10234, 10235, 10236, 10237, 10238, 10239, 10240, 10241, 10242, 10243, 10244, 10245, 10246, 10247, 10248, 10249, 10250, 10251, 10252, 10253, 10254, 10255, 10256, 10257, 10258, 10259, 10260, 10261, 10262, 10263, 10264, 10265, 10266, 10267, 10268, 10269, 10270, 10271, 10272, 10273, 10274, 10275, 10276, 10277, 10278, 10279, 10280, 10281, 10284, 10285, 10286, 10287, 10288, 10289, 10290, 10291, 10292, 10293, 10294, 10298, 10299, 10300, 10301, 12000, 12001, 12002, 12003, 12004, 12005, 12006, 12007, 12008, 12009, 396001, 396003, 396004, 396005, 396006, 396007, 396008, 396009, 396010, 396011

What the firm is doing

An "URGENT Medical Device Correction" notice dated 5/21/25 was mailed to consignees. The notification instructs consignees on how to identify if their devices have affected software downloaded. Consignees may continue to use affected systems in accordance with the intended use and recommended actions provided in the recall notification in Appendix A. Appendix A summarizes the ten software issues and the actions recommended by the manufacturer that the consignee follow. Consignees are to complete and return the provided response form, forward the recall notification to users, and retain a copy with all affected systems until a solution is installed. Philips will contact consignees to schedule time for a Field Service Engineer to install the solution and resolve the issue (Reference FCO72800828/FCO 72800829). Consignees with any questions can contact Customer Care Solutions at 1-800-722-9377.

DistributionShow details

Domestic: AZ, CA, CO, FL, GA, HI, IN, KY, MA, MD, MN, NY, OH, OR, PA, TX, VT, WA, WV; Foreign: Australia, Austria, Belgium, China, Czech Republic, Denmark, Ecuador, France, Germany, Hong Kong, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Lithuania, Macao, Malaysia, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand, United Kingdom, Vietnam.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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