Leica Microsystems, Inc. recalls Leica M220 F12 surgical microscope The Leica M220 F12 surgical microscope is an optical instrument for improving the vi…

Recall date

January 2, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0772-2019

FDA classification

Class II

Brand / firm

Leica Microsystems, Inc.

Sold / distributed

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, Ro…

Why it was recalled

The M220 optics may unintentionally drop into the surgical field, risking contact with the patient.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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.