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Leica Microsystems, Inc. recalls Leica M525 F50 Surgical Microscope; Article No. 10338422; Leica Microsystems (Schweiz) Ag, 201 Max Schmidheiny Strasse,
Recalled August 1, 2012 · FDA recall Z-2053-2012 · Leica Microsystems
Hazard
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 Class II
Units
39 Units - USA , 4 Units - Canada
Sold at
Worldwide 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.
Description
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.
Product
Leica 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.
Manufacturer(s)
Leica Microsystems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →