Reported Apr 27, 2016 · Terminated
Leica Microsystems (Schweiz) Ag. The common name of the device is surgical microscope. It has been assigned the product…
Leica Microsystems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Leica Microsystems, Inc. · 1700 Leider Ln · Buffalo Grove, IL · 60089-6622
Is this the product you have?
- Leica Microsystems (Schweiz) Ag. The common name of the device is surgical microscope. It has been assigned the product code FSO by the FDA and is classified as a Class I medical device. Intended for improving the visibility of objects through magnification and illumination.
- Lot codes and dates
208 of 208 products
Products covered by this recall # Product as published 1 OH5-51313 2 OH4-112214 3 OH5-49112 4 OH5-67914 5 OH4-101213 6 OH5-20238 7 OH4-91913 8 OH5-43312 9 OH5-54113 10 OH5-64514 11 OH4-103014 12 OH4-106514 13 OH4-87112 14 OH4-95413 15 OH4-94213 16 OH4-106014 17 OH4-105514 18 OH4-94813 19 OH4-102514 20 OH4-91113 - Amount recalled
- 381 units
Where it was sold
Why it was recalled
An electronic component of the Leica M525 OH4 and Leica M720 OH5 surgical microscopes with 400W illumination could potentially overheat, resulting in smoke and smell emanating from the ventilation openings of the illumination units located opposite and away from the surgeon / patient side of the surgical microscope.
This product could cause temporary or reversible health problems — stop using it.
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