Recall Z-0306-2024 ยท JAK System, X-Ray, Tomography, Computed
Philips North America
Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
| Date | Nov 15, 2023 (initiated Oct 9, 2023) |
| Status | Open, Classified |
| Reason | When preparing for CCT Fluoroscopy mode and activating the CCT foot pedal simultaneously, the operator may experience a software crash. This would result in the system needing to be restarted. |
| Root cause | Under Investigation by firm |
| Action | An URGENT Medical Device Correction notification letter dated 10/9/23 was sent to customers. Actions that should be taken by the customer / user in order to prevent risks for patients or users. Below are short-term precautions to take until the permanent solution is installed. Leave the audible preparation indication alert turned on, set as default in the factory settings, and wait for the audible alert before pressing the foot pedal. If you have disabled the audible alert, you can turn it back on by following instructions provided in Section 4: Preparing for an Examination of the IFU. Wait |
| Quantity | 1 unit |
| Distribution | US Nationwide distribution in the state of 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 |