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U.S. Department of Health and Human Services

Class 2 Device Recall Leica M520 Surgical Microscope Systems

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  Class 2 Device Recall Leica M520 Surgical Microscope Systems see related information
Date Initiated by Firm April 12, 2005
Date Posted June 24, 2006
Recall Status1 Terminated 3 on May 09, 2008
Recall Number Z-1162-06
Recall Event ID 35385
Product Classification Surgical Microscope - Product Code EPT
Product Leica M520 Surgical Microscope; a surgical microscope with a 6:1 motorized zoom magnification, 207-470 mm motorized Multi-Foc variable objective lens with diameter and light intensity of illuminated field continuously adjustable and high power 300W xenon lamp (both main and back-up illimuniation) through fiber optic cable; Leica Microsystems (Schweiz) AG, Business Unit SOM, Max Schmidheiny-Strasse 201, CH-9435 Heerbrugg, Switzerland; Leica Microsystems Inc., 90 Boroline Road, Allendale, NJ 07401; Leica Microsystems Inc., 2345 Waukegan Road, Bannockburn, IL 60015-9792

The M520 microscope was sold with the following floor stands to form Leica Surgical Microscope Systems:
a) MS-1 floor stand with manual balancing for the microscope carrier in three axes and three electromagnetic and mechanical brakes;
b) MS-2 floor stand with 3 step balancing for the optical head, autobalance for the floor stand and six electromagnetic brakes;
c) MS-3 floor stand with semi-automatic balancing system and six electromagnetic permanent magnetic brakes, cantilever range: 1456 mm
d) ) OHS1 floor stand with semi-automatic balancing system and six electromagnetic permanent magnetic brakes,
e) OH3 floor stand with fully-automatic balancing system and six electromagnetic permanent magnetic brakes, cantilever range: Max. 1520 mm
f) F40 floor stand with continuously adjustable balancing system and four electromagnetic permanent magnetic brakes, Maximum reach 1496 mm
Code Information All units shipped prior to December 1, 2005
Recalling Firm/
Manufacturer		 Leica Microsystems, Inc.
2345 Waukegan Rd
Bannockburn IL 60015-1515
For Additional Information Contact Mr. Michael Gafron
847-317-7211
Manufacturer Reason
for Recall		 Patient Burns-The use of the surgical microscope at high light intensity and short working distances can result in patient burns.
FDA Determined
Cause 2		 Other
Action Leica Microsystems faxed a memo entitled 'M520 Heat Issues' to all IMRs on 11/15/05, informing them that the potential to burn exposed patient skin at the closer working distances with the high intensity of light exists with the M520 optics carrier and/or new optichrome light source. The IMRs were sent retrofit packets which consisted of a current User Manual with 'Caution: The light source in this unit may be too bright at shorter focal lengths for surgeon and patient. Please start with light low and turn up till the surgeon has an excellent optical image.'; a sticker reading 'Warning: Maximum Light at Short Distance Can Injure Patient See User Manual', to be placed on the stand near the light intensity controller; a laminated card entitled 'Setting the Illumination Intensity' to be hung on the stand with the enclosed wire tie for in-service training; and a training verification form. The IMRs were instructed to visit each of the end user locations on the enclosed list, installing the stickers, providing the new User Manual and providing the staff that uses the microscope another in-service, stressing the proper use of the illumination system. Upon completion of the in-service, the IMRs will complete the training verification form and have a staff member from the OR sign the form verifying that the warning labels were applied and that the staff was trained, and that the user manual was received. The IMRs will then return the verification form to Leica Microsystems.
Quantity in Commerce 581 systems
Distribution Nationwide
Total Product Life Cycle TPLC 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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