Leica Ceiling Mount MS-1F & MC-1F for use with the M500 N operating microscope. Article Number 10446657 utilizes a suppl

FDA device recall Z-1726-2014 · posted 2014-06-07 · Terminated

Recall details

Recalling firm

Leica Microsystems, Inc.

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).

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

OUE

Quantity affected

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,

Date initiated

2013-09-11

Date posted

2014-06-07

Date terminated

2017-04-24

Location

Buffalo Grove, IL