Recall Z-0412-2022— Leica Microsystems, Inc.
Class II · Terminated
Class II FDA medical device recall by Leica Microsystems, Inc., initiated 2021-11-03, terminated 2024-06-18. FDA's recall record names no specific 510(k) clearance for this event. Product: Leica Microsystems M220 F12 Microscope Systems. Reason: In May 2021, Leica Microsystems received one (1) complaint pertaining to the M220 F12 Surgical Microscope system. There was no patient injury reported for this complaint. However, the identified defect carries some potential injury risk. In the event that this defect may occur, the M220 optics carrier may unintentionally drop into the surgical field, risking contact with the patient..
- Recalling firm
- Leica Microsystems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-11-03
- Terminated
- 2024-06-18
- Firm location
- Buffalo Grove, IL, United States
Product description
Leica Microsystems M220 F12 Microscope Systems
Reason for recall
In May 2021, Leica Microsystems received one (1) complaint pertaining to the M220 F12 Surgical Microscope system. There was no patient injury reported for this complaint. However, the identified defect carries some potential injury risk. In the event that this defect may occur, the M220 optics carrier may unintentionally drop into the surgical field, risking contact with the patient.
Data sourced from openFDA. This site is unofficial and independent of the FDA.