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U.S. Department of Health and Human Services

Class 2 Device Recall Leica M822 Surgical Microscope

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 Class 2 Device Recall Leica M822 Surgical Microscopesee related information
Date Initiated by FirmDecember 21, 2011
Date PostedFebruary 16, 2012
Recall Status1 Terminated 3 on February 16, 2012
Recall NumberZ-1042-2012
Recall Event ID 60866
Product Classification Stimulator, caloric-water - Product Code ETP
ProductLeica 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.
Code Information Article 10448446, serial numbers 181011001, 181011009, 181011005, 181011003, 250811007, 28101108, 151111011, 211111007, 251111006 and 251111004. The corrected units will have controller software version MDC V3.6 pack G
Recalling Firm/
Manufacturer		 Leica Microsystems, Inc.
1700 Leider Ln
Buffalo Grove IL 60089-6622
For Additional Information ContactMs. M. Elizabeth Culotta
847-405-6565
Manufacturer Reason
for Recall		Leica Microsystems received complaints stating that the zoom function of the Leica M822 surgical microscope locked up during use.
FDA Determined
Cause 2		Device Design
ActionThe 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 elizabeth.culotta@leica-microsystems.com. 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.
Quantity in Commerce29 units (10 units-USA)
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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