PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: January 30, 2019 Initiated: January 2, 2019 #Z-0772-2019

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.

Details

Recalling Firm
Leica Microsystems, Inc.
Units Affected
15 units
Distribution
Worldwide distribution: US (nationwide) and countries of: Albania, Algeria, Armenia, Argentina, Bangladesh, Brazil, Burundi, Canada, China, Colombia, Egypt, France, Germany, Guatemala, India, Indonesia, Japan, Nepal, Netherlands, New Zealand, Malaysia, Pakistan, Peru, Philippines, Poland, Qatar, Romania, Russia Federation, Saudi Arabia, Senegal, Spain, South Africa, South Korea, Switzerland, Tanzania, Thailand, Turkey, Ukraine, and Vietnam.
Location
Buffalo Grove, IL

Frequently Asked Questions

What product was recalled?
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.. Recalled by Leica Microsystems, Inc.. Units affected: 15 units.
Why was this product recalled?
The M220 optics may unintentionally drop into the surgical field, risking contact with the patient.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 30, 2019. Severity: Moderate. Recall number: Z-0772-2019.