Leica M525 F20 Surgical Microscope System
FDA Recall Z-3175-2018 · Posted 2018-09-14
Recalling FirmLeica Microsystems, Inc.
Recall StatusTerminated
Product CodeEPT
Date Initiated2018-09-04
Date Terminated2021-08-17
Product Quantity160 units
Reason for Recall
The firm received complaints that the instrument tipped over when the swing arm was fully extended.
Firm 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.
Root Cause
Device Design
Distribution Pattern
US and Canada
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.