Recall Z-3175-2018 ยท EPT Microscope, Surgical
Leica Microsystems, Inc.
Leica M525 F20 Surgical Microscope System
| Date | Sep 14, 2018 (initiated Sep 4, 2018) |
| Status | Terminated |
| Reason | The firm received complaints that the instrument tipped over when the swing arm was fully extended. |
| Root cause | Device Design |
| Action | The firm disseminated their Field Corrective Action Notices by mail beginning on 09/04/2018 to the US and Canadian consignees. The letter explained the problem and informed the consignee that an update package with enhanced instructions for use and additional marking will be provided within the next 3 months. Additional consignees found were notified by email on 10/01/2018. |
| Quantity | 160 units |
| Distribution | US and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.