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U.S. Department of Health and Human Services

Class 2 Device Recall Leica M720 OH5

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 Class 2 Device Recall Leica M720 OH5see related information
Date Initiated by FirmDecember 18, 2012
Date PostedSeptember 10, 2013
Recall Status1 Terminated 3 on April 24, 2017
Recall NumberZ-2177-2013
Recall Event ID 64601
Product Classification Microscope, surgical, general & plastic surgery - Product Code FSO
ProductSurgical microscope The device is used to improve the visibility of objects through magnification and illumination and can be applied for observation and documentation and for human veterinary medical treatment.
Code Information Serial Numbers: OH5-45912,  OH5-46012,  OH5-46112,  OH5-46212,  OH5-46312,  OH5-46412,  OH5-46512,  OH5-46612,  OH5-46712,  OH5-46912,  OH5-47012,  OH5-47112,  OH5-47212,  OH5-47312,  OH5-47412,  OH5-47512,  OH5-47612,  OH5-47812,  OH5-47912,  OH5-48012,  OH5-48112,  OH5-48212,  OH5-48312,  OH5-48312 
Recalling Firm/
Manufacturer		 Leica Microsystems (Schweiz) Ag
201 Max Schmidheiny-Strasse
Heerbrugg Switzerland
For Additional Information ContactMs. Katya MaGee
847-405-5413
Manufacturer Reason
for Recall		The brake in the Z axis and/or brakes in the AB and C axes failed during installation.
FDA Determined
Cause 2		Device Design
ActionThe firm, Leica Microsystems, sent an "URGENT MEDICAL DEVICE RECALL" letter dated December 19, 2012 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to DISCONTINUE USE until your system software is updated and to complete and return the attached Acknowledgement Form via email at LMGRA@leica-microsystems.com or fax to: 847-236-3747 or +41 71 726 32 49 within 10 working days after receipt of field safety notice. Your Leica Mycrosystems will contact you to make the necessary arrangements to complete an upgrade at no charge to the customers. If you have any further questions, contact Regulatory Affairs/Quality Assurance Manager at 847-405-5413 or +41 71 726 32 16.
Quantity in Commerce28 units
DistributionWorldwide distribution: USA (Nationwide) including states of: AK, CA, CO, NY, and OR; and countries of: Belarus, China, Hong Kong, India, Indonesia, Italy, Norway, South Africa, Spain, Sweden, Turkey, and Vietnam.
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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