Leica M525 F20 Surgical Microscope System
FDA device recall Z-3175-2018 · posted 2018-09-14 · Terminated
Recall details
- Recalling firm
- Leica Microsystems, Inc.
- Reason for recall
- The firm received complaints that the instrument tipped over when the swing arm was fully extended.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- EPT
- Quantity affected
- 160 units
- Distribution
- US and Canada
- Date initiated
- 2018-09-04
- Date posted
- 2018-09-14
- Date terminated
- 2021-08-17
- Location
- Buffalo Grove, IL
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