Philips North America Llc: Spectral CT. Computed tomography X-ray system.

Recall number

Z-2034-2025

Recalling firm

Philips North America Llc

Product

Spectral CT. Computed tomography X-ray system.

Status

Open, Classified

Initiated

2025-05-29

Posted

2025-06-26

Terminated

not on file

Reason

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.

Root 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

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.

Lot, serial or model codes

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, 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(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, 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510(k) numbers

["K203020"]

PMA numbers

not on file

Product code

JAK

Firm FEI

3016618143

Firm city

Cambridge

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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