Recall Z-0319-2024 ยท JAK System, X-Ray, Tomography, Computed
Philips North America
Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
| Date | Nov 16, 2023 (initiated Oct 9, 2023) |
| Status | Open, Classified |
| Reason | This recall is part of a 2-issue recall for the same system. When using the IVC needle position button, on the IVC control box during a series of scans, the plan box may not move to the desired needle position. This issue could result in the gantry moving to a location the operator does not expect. If this occurs, it presents a risk that the scan could occur at an incorrect location, or that the unintended motion of the gantry could cause a collision with the user or needle. The other part of the recall involves a software crash when the CCT foot pedal is activated (as described in RES ID9336 |
| 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. Remain vigilant and confirm gantry position during procedures. Review the Emergency Stop Procedure and Collision Prevention Guidelines provided in Section 6: Working with Specialized Exams of the IFU. Actions planned by Philips to correct the problem Philips will contact you to schedule a time for a Philips Field Serv |
| 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 |