Recall Z-0772-2019— Leica Microsystems, Inc.
Class II · Terminated
Class II FDA medical device recall by Leica Microsystems, Inc., initiated 2019-01-02, terminated 2021-04-02. FDA's recall record names no specific 510(k) clearance for this event. Product: Leica M220 F12 surgical microscope The Leica M220 F12 surgical microscope is an optical instrument for improving the visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment.. Reason: The M220 optics may unintentionally drop into the surgical field, risking contact with the patient..
- Recalling firm
- Leica Microsystems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-01-02
- Terminated
- 2021-04-02
- Firm location
- Buffalo Grove, IL, United States
Product description
Leica M220 F12 surgical microscope The Leica M220 F12 surgical microscope is an optical instrument for improving the visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment.
Reason for recall
The M220 optics 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.