Leica Microsystems Ag recalled over fire hazard

Recall date

January 11, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Leica Microsystems, Inc. recalls Leica Microsystems (Schweiz) Ag. The common name of the device is surgical microscope. It has been assigned the product…

Recall number

Z-1499-2016

FDA classification

Class II

Brand / firm

Leica Microsystems, Inc.

Sold / distributed

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, Gre…

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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.