Recall Z-0274-2024 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Philips North America Llc
DigitalDiagnost 4 High Performance, used to acquire, process, store, display and export digital radiographic images.
| Date | Nov 8, 2023 (initiated Sep 21, 2023) |
| Status | Open, Classified |
| Reason | Potential for units suspended on the ceiling to fail and fall. |
| Root cause | Under Investigation by firm |
| Action | The firm distributed recall notifications dated 8/31/2023 via FedEx to affected consignees. Consignees are instructed to immediately stop use of affected devices and contact their local Philips service representative if the Ceiling Suspension becomes unstable, if moving the Ceiling Suspended X-Ray Tube requires a high amount of force, or if moving the Ceiling Suspended X-Ray Tube is noticeably hampered. The recall notice is to be circulated among all device users, so they are aware of this issue and placed as an addendum in the IFU. Consignees are to complete the provided response form and ret |
| Quantity | 366 units |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K210692 | DigitalDiagnost Philips Medical Systems Dmc GmbH, Apr 2, 2021 |