FDA Recall
Terminated
Leica M525 F20 Surgical Microscope System
Recall: Z-3175-2018
·
Initiated September 4, 2018
Recall
- Recall Number
- Z-3175-2018
- Event Number
- 80979
- Firm
- Leica Microsystems, Inc.
- FEI Number
- 3000210133
- Product Code
- EPT
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- September 4, 2018
- Posted
- September 14, 2018
- Terminated
- August 17, 2021
- Address
- 1700 Leider Ln, Buffalo Grove, IL, 60089-6622
Description
Leica M525 F20 Surgical Microscope System
Reason
The firm received complaints that the instrument tipped over when the swing arm was fully extended.
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.
Distribution
US and Canada
Quantity
160 units