Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Leica M525 F50 surgical microscope

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Leica M525 F50 surgical microscopesee related information
Date Initiated by FirmJune 04, 2012
Date PostedJuly 20, 2012
Recall Status1 Terminated 3 on October 29, 2012
Recall NumberZ-2053-2012
Recall Event ID 62114
Product Classification Microscope, surgical, general & plastic surgery - Product Code FSO
ProductLeica M525 F50 Surgical Microscope; Article No. 10338422; Leica Microsystems (Schweiz) Ag, 201 Max Schmidheiny Strasse, Heerbrugg, Switzerland Product Usage: The intended use of this device is for improving visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment.
Code Information Serial numbers serial numbers 110311001, 120312001, 20412001, 260112001, 300911001, 40811001, 80411001, 90312001, 10311002, 90611001, 260711001, 20911001, 200911001, 210911001, 111011001, 141011001, 241011001, 121211001, 141211001, 151211001, 191211001, 30112001, 50112001, 140212001, 60312001, 220312001, 300312001, 30412001, 50411001, 10411001, 130411001, 210411001, 170511001, 300511001, 90811001, 200312001, 50412001, 110112002, 280611001, 241011002, 20312001, 101011001 and 270911001
Recalling Firm/
Manufacturer		 Leica Microsystems, Inc.
1700 Leider Ln
Buffalo Grove IL 60089-6622
For Additional Information ContactMs. M. Elizabeth Culotta
847-317-7209
Manufacturer Reason
for Recall		Leica Microsystems evaluated data showing that a malfunction resulting in an illumination reduction can be observed when Leica M525 F50 surgical microscope is used in combination with a remote control connected to a remote video adapter or motorized dual video adapter.
FDA Determined
Cause 2		Software design
ActionLeica Microsystems sent an Urgent Medical Device letter dated June 4, 2012 to the affected customers. The letter described the product, problem and actions to be taken. The customers were informed that the Leica surgical microscope M525 F50 required a software upgrade. Customers were instructed to NOT USE a remote video adapter or motorized video adapter until the required software upgrade has been installed by their Leica Microsystems representative. The customers were requested to complete the attached Acknowledgement Form, acknowledging receipt and understanding of the letter, listing the serial numbers of the units at their facilities and to fax it back to Leica Microsystems at (847) 236-3747.
Quantity in Commerce39 Units - USA , 4 Units - Canada
DistributionWorldwide Distribution - US (nationwide) in the states of: California, Colorado, Florida, Georgia, Illinois, Indiana, Massachusetts, Michigan, Minnesota, New York, Oklahoma, Oregon, Pennsylvania, Texas, Utah, West Virginia, including Puerto Rico, and the countriy of Canada.
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.
-
-