• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of August 1, 2012

  • Print
  • Share
  • E-mail
-

Product Detail

Product Description 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.
Recall Number Z-2053-2012
Classification Class II
Code Info 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.
Product Distributed Qty 39 Units - USA , 4 Units - Canada
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.

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.
-
-