Recall Z-1324-2025 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems Nederland B.V.
Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;
| Date | Mar 12, 2025 (initiated Feb 28, 2025) |
| Status | Open, Classified |
| Reason | Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement. |
| Root cause | Under Investigation by firm |
| Action | On February 28, 2025 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Actions that should be taken by the customer / user in order to prevent risks for patients or users. " You may continue to use your system(s) in accordance with the intended use and by following the recommendation listed below. " When you see the warning message No communication with table and C-arm. Avoid collisions, Proceed with caution., acknowledge the message by selecting OK and continue using the CT while observing with extra care, collision with the Gantry and C-arm can be avoided. " To protect the pat |
| Quantity | 1 unit |
| Distribution | Domestic: MN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K212875 | Spectral CT on Rails Philips Medical Systems Nederland B.V., May 13, 2022 |