Recall Z-2399-2020— Leica Microsystems, Inc.
Class II · Terminated
Class II FDA medical device recall by Leica Microsystems, Inc., initiated 2020-05-20, terminated 2021-05-13. FDA's recall record names no specific 510(k) clearance for this event. Product: Leica ARveo and M530 OH6 microscope systems.. Reason: Possible unintended interruption of surgical procedures due to equipment shutdown, related to changes in voltage..
- Recalling firm
- Leica Microsystems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-05-20
- Terminated
- 2021-05-13
- Firm location
- Buffalo Grove, IL, United States
Product description
Leica ARveo and M530 OH6 microscope systems.
Reason for recall
Possible unintended interruption of surgical procedures due to equipment shutdown, related to changes in voltage.
Data sourced from openFDA. This site is unofficial and independent of the FDA.