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Recall Observatory FDA recall evidence

Device product

Leica Ceiling Mount MS-1F & MC-1F for use with the M500 N operating microscope. Article Number 10446657 utilizes a supply voltage of 110 V. Article Number 10446658 utilizes a supply voltage of 220 V. Intended to be used for improving the visibility of objects through magnification and illumination.

Z-1726-2014

September 11, 2013

Class II

Product summary

Firm
Leica Microsystems, Inc.
Event
Event 66274
Status
Terminated
Classification
Class II
Quantity
103 total
Official record key
device-enforcement:Z-1726-2014

Official wording

Reason: 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).

Code information: Leica Ceiling Mounts MS-1F, MC-1F; Article Numbers: 10446657, 10446658

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).