Spectral CT. Computed tomography X-ray system.
- Company
- Philips North America Llc
- Recall Initiated
- May 29, 2025
- Posted
- June 26, 2025
- Recall Number
- Z-2034-2025
- Quantity
- 370 units
- Firm Location
- Cambridge, MA
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.
Distribution
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.
Lot / Code Info
Part No. 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, (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)10231, (01)00884838101111(21)10232, (01)00884838101111(21)10233, (01)00884838101111(21)10234, (01)00884838101111(21)10235, (01)00884838101111(21)10236, (01)00884838101111(21)10237, (01)00884838101111(21)10238, (01)00884838101111(21)10239, (01)00884838101111(21)10240, (01)00884838101111(21)10241, (01)00884838101111(21)10242, (01)00884838101111(21)10243, (01)00884838101111(21)10244, (01)00884838101111(21)10245, (01)00884838101111(21)10246, (01)00884838101111(21)10247, (01)00884838101111(21)10248, (01)00884838101111(21)10249, (01)00884838101111(21)10250, (01)00884838101111(21)10251, (01)00884838101111(21)10252, (01)00884838101111(21)10253, (01)00884838101111(21)10254, (01)00884838101111(21)10255, (01)00884838101111(21)10256, (01)00884838101111(21)10257, (01)00884838101111(21)10258, (01)00884838101111(21)10259, (01)00884838101111(21)10260, (01)00884838101111(21)10261, (01)00884838101111(21)10262, (01)00884838101111(21)10263, (01)00884838101111(21)10264, (01)00884838101111(21)10265, (01)00884838101111(21)10266, (01)00884838101111(21)10267, (01)00884838101111(21)10268, (01)00884838101111(21)10269, (01)00884838101111(21)10270, (01)00884838101111(21)10271, (01)00884838101111(21)10272, (01)00884838101111(21)10273, (01)00884838101111(21)10274, (01)00884838101111(21)10275, (01)00884838101111(21)10276, (01)00884838101111(21)10277, (01)00884838101111(21)10278, (01)00884838101111(21)10279, (01)00884838101111(21)10280, (01)00884838101111(21)10281, (01)00884838101111(21)10284, (01)00884838101111(21)10285, (01)00884838101111(21)10286, (01)00884838101111(21)10287, (01)00884838101111(21)10288, (01)00884838101111(21)10289, (01)00884838101111(21)10290, (01)00884838101111(21)10291, (01)00884838101111(21)10292, (01)00884838101111(21)10293, (01)00884838101111(21)10294, (01)00884838101111(21)10298, (01)00884838101111(21)10299, (01)00884838101111(21)10300, (01)00884838101111(21)10301, (01)00884838101111(21)12000, (01)00884838101111(21)12001, (01)00884838101111(21)12002, (01)00884838101111(21)12003, (01)00884838101111(21)12004, (01)00884838101111(21)12005, (01)00884838101111(21)12006, (01)00884838101111(21)12007, (01)00884838101111(21)12008, (01)00884838101111(21)12009, (01)00884838101111(21)396001, (01)00884838101111(21)396003, (01)00884838101111(21)396004, (01)00884838101111(21)396005, (01)00884838101111(21)396006, (01)00884838101111(21)396007, (01)00884838101111(21)396008, (01)00884838101111(21)396009, (01)00884838101111(21)396010, (01)00884838101111(21)396011; Serial No. 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.
Root Cause
Under Investigation by firm
Action Taken
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.