PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: August 1, 2012 Initiated: June 4, 2012 #Z-2053-2012

Product Description

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.

Reason for Recall

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.

Details

Recalling Firm
Leica Microsystems, Inc.
Units Affected
39 Units - USA , 4 Units - Canada
Distribution
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.
Location
Buffalo Grove, IL

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Leica Microsystems, Inc.. Units affected: 39 Units - USA , 4 Units - Canada.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 1, 2012. Severity: Moderate. Recall number: Z-2053-2012.

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