Spectral CT. Computed tomography X-ray system.

FDA device recall Z-2034-2025 · posted 2025-06-26 · Open, Classified

Recall details

Recalling firm

Philips North America Llc

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.

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

JAK

Quantity affected

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,

Date initiated

2025-05-29

Date posted

2025-06-26

Location

Cambridge, MA

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