Recall Z-2843-2018 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Philips Medical Systems Gmbh, DMC
DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031
| Date | Aug 17, 2018 (initiated Jun 27, 2018) |
| Status | Terminated |
| Reason | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient. |
| Root cause | Device Design |
| Action | On June 27, 2018, Philips Medical Systems issued URGENT FIELD SAFETY NOTICES, Medical Device Recall letters to customers. Customers were encouraged to always check the right position of the hook and ensure that the hook is locked according tot he IFU. Press hook down until it is locked. Make sure that the hook is in position. A Philips Service Engineer will contact impacted customers as soon as the Field Action Kit is ready to be implemented. Should you need to communicate with Philips in regards to this program, please reference FCO-71200185. If you need further information or support c |
| Distribution | US Nationwide; International to 66 countries |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090625 | WIRELESS PORTABLE DETECTOR FD-W17 Philips Medical Systems North America Co., Mar 24, 2009 |