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U.S. Department of Health and Human Services

Class 2 Device Recall Leica Ceiling Mount MSF1

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 Class 2 Recall
Leica Ceiling Mount MSF1
see related information
Date Posted June 07, 2014
Recall Status1 Open
Recall Number Z-1725-2014
Recall Event ID 66274
Product Classification Micro Total Analysis Instrument System - Product Code OUE
Product Leica Ceiling Mount MSF-1 for use with M841 and M501 operating microscopes. Article Number 10446781 utilizes a supply voltage of 230 V. Article Number 10446782 utilizes a supply voltage of 110 V. Intended to be used for improving the visibility of objects through magnification and illumination.
Code Information Leica Ceiling Mount MSF-1; Article Numbers: 10446781, 10446782
Recalling Firm/
Manufacturer
Leica Microsystems, Inc.
1700 Leider Ln
Buffalo Grove, Illinois 60089-6622
For Additional Information Contact Ms. Katya Magee
847-405-5413
Manufacturer Reason
for Recall
The ceiling mount supplier encountered an event in which the drive screw in the motor unit, which lifts and lowers the lower lift arm, broke. As a result, the lift arm fell down approx. 60 cm (23.6 inches).
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action A Medical Device Correction letter, dated September 11, 2013, was sent to all direct accounts. The letters advised customers that a Leica Microsystems representative will contact them and make arrangements to conduct an inspection of the ceiling mount(s) and to provide additional preventative maintenance and inspection protocols for the devices. Customers are asked to complete and return the enclosed Acknowledgement Form and send it back to Leica Microsystems within 10 days of receiving the Medical Device Correction letter. Customers with questions should contact their Leica Microsystems representative.
Quantity in Commerce 103 total
Distribution Worldwide Distribution -- USA, including the states of AZ, IL, MA, MO, NC, OR, TX, VA, and WI; and, the countries of Australia, Austria, Chile, China, Colombia, Czech Republic, Greece, Israel, Italy, Japan, Malaysia, Netherlands, Norway, Oman, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, and United Kingdom.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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