Class 2 Device Recall Spectral CT

• Date Initiated by Firm: May 29, 2025
• Date Posted: June 26, 2025
• Recall Status: Open, Classified
• Recall Number: Z-2034-2025
• Recall Event ID: 97010
• 510(K)Number: K203020
• Product Classification: System, x-ray, tomography, computed - Product Code JAK
• Product: Spectral CT. Computed tomography X-ray system.
• Code Information: 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.
• Recalling Firm/ Manufacturer: Philips North America Llc; 222 Jacobs St; Cambridge MA 02141-2289
• For Additional Information Contact: Philips Customer Care Solutions Center; 1-800-722-9377
• Manufacturer 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.
• FDA Determined Cause: Under Investigation by firm
• Action: 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.
• Quantity in Commerce: 370 units
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = JAK