Recall Z-2034-2025 ยท JAK System, X-Ray, Tomography, Computed
Philips North America Llc
Spectral CT. Computed tomography X-ray system.
| Date | Jun 26, 2025 (initiated May 29, 2025) |
| Status | Open, Classified |
| 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 |
| 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 Zeal |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K203020 | Spectral CT Philips Medical Systems Nederland B.V., Feb 26, 2021 |