PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: April 27, 2016 Initiated: January 11, 2016 #Z-1499-2016

Product Description

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.

Reason for Recall

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.

Details

Recalling Firm
Leica Microsystems, Inc.
Units Affected
381 units
Distribution
Worldwide Distribution-US (nationwide) including Puerto Rico and the states of MA, CA, SC, NJ, TX, CO, FL, PA, NY, MO, WI, NC, UT, ID, AZ, MI, KY, CT, OR, , IL, AL, MN, MT, OH, NE, GA, IN, SD, TN, OK, AK, KS, NV, NM, , ND, VA, WA, WY and MD, and the countries of China, Belgium, France, Germany, Great Britain, Italy, Norway, Portugal, Spain, Sweden, Switzerland, India, Japan, Argentina, Chile, Colombia, Mexico, Peru, Belarus, Egypt, Greece, Morocco, Poland, Qatar, Romania, Russian Fed., Saudi Arabia, South Africa, Turkey, Canada, , Australia, Malaysia and Taiwan.
Location
Buffalo Grove, IL

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Leica Microsystems, Inc.. Units affected: 381 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 27, 2016. Severity: Moderate. Recall number: Z-1499-2016.

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