EasyDiagnost Eleva DRF, Release 5 (Stitching Patient Support) 706050
FDA device recall Z-2868-2018 · posted 2018-08-17 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems Gmbh, DMC
- Reason for recall
- 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.
- Action taken
- 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 concerning this issue, please contact your local Philips representative.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MQB
- Distribution
- US Nationwide; International to 66 countries
- Date initiated
- 2018-06-27
- Date posted
- 2018-08-17
- Date terminated
- 2024-04-30
- Location
- Hamburg, Germany
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| WIRELESS PORTABLE DETECTOR FD-W17 (K090625) | Philips Medical Systems North America Co. | 2009-03-24 |