26

Feb

2012

Cl ll Leica M822 Surgical Microscope Control SW

0

Company:Leica Microsystems, Inc.
Date of Enforcement Report 2/22/12
Class ll:

PRODUCT
Leica M822 Surgical Microscope Device Controller Software (MDC version 3.6, pack F, affecting the control unit component, Article #10448446, in combination with a Leica M822 Optics Carrier-XY-Focus-Tilt-Unit, article #10448587; Leica Microsystems (Schweiz) AG, Max Schmidheiny-Strasse 201. The intended use of the microscope is 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. The corrected units will have controller software version MDC V3.6 pack G. Recall # Z-1042-2012

REASON
Leica Microsystems received complaints stating that the zoom function of the Leica M822 surgical microscope locked up during use.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Leica Microsystems, Inc., Buffalo Grove, IL, by e-mail on December 21,2011.
Manufacturer: Leica Microsystems (Schweiz) Ag, Heerbrugg, Switzerland. Firm initiated recall is complete.

VOLUME OF PRODUCT IN COMMERCE
29 units

DISTRIBUTION
Nationwide, Austraila, Japan, Korea, Pakistan, Romania, South Africa, Switzerland and Turkey

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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