Enforcement Report - Week of August 1, 2012
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Event Detail
| Event ID | 62114 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Leica Microsystems, Inc. |
| City | Buffalo Grove |
| State | IL |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-06-04 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | 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. |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| Leica M525 F50 Surgical Microscope; Article No. 10338422; 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. | United States, Serial numbers :260112001, 120312001, 20412001, 80411001, 110311001. 300911001, 40811001, 90312001, 10311002, 90611001, 260711001, 20911001, 210911001, 111011001, 141011001, 151211001, 191211001, 30112001, 50112001, 140212001, 60312001, 220312001, 300312001, 30412001, 50411001, 10411001, 130411001, 210411001, 170511001, 300511001, 190811001, 200312001, 50412001, 110112002, 28611001, 241011002, 20312001, 101011001 and 270911001; Canada Serial Numbers 50111001, 20312001, 200312001 and 101011001. | Class II | 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. | 39 Units - USA , 4 Units - Canada | Z-2053-2012 |
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