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, CH-9425, Heerbrugg, Switzerland 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.
FDA Recall Z-1042-2012 · Posted 2012-02-16
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Recalling FirmLeica Microsystems, Inc.
Recall StatusTerminated
Product CodeETP
Date Initiated2011-12-21
Date Terminated2012-02-16
Product Quantity29 units (10 units-USA)
Reason for Recall
Leica Microsystems received complaints stating that the zoom function of the Leica M822 surgical microscope locked up during use.
Firm Action
The firm, Leica Microsystems, Inc., sent a "Medical Device Correction" notice dated December 21, 2011 to all affected customers by e-mail. The product, problem, and actions to be taken by the customers were addressed. Customers were instructed- DO NOT USE use the affected product until the software could be upgraded and complete and return the Acknowledgement Form via fax to: 1-847-607-3147 or Scan and send to [email protected]. Leica Microsystems representatives will contact the customers to make necessary arrangements to complete the software upgrade.
If you have any questions, contact Director, Global Product Quality Management at 1-847-317-7209.
Root Cause
Device Design
Distribution Pattern
Worldwide distribution: USA (nationwide) including states of: California, Colorado, Illinois, New York, Oregon, South Carolina; and countries of: Australia, Japan, Korea, Pakistan, Romania, South Africa, Switzerland and Turkey.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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