Leica M220 F12 Microscope System (2018-12-16)

Starting date:

December 16, 2018

Posting date:

January 23, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-68892

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  Reason
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  Affected products

Affected products

Leica  M220 F12 Microscope System

Reason

Leica Microsystems has received two (2) (Nov. 2018) complaints pertaining to the M220 F12 Surgical Microscope System. In both, the optics carrier were reported to have fallen. These complaints detailed mechanical part failures with the screw that connects the optics carrier to the free end of the swing arm. Leica identified the cause of the observed issues to be insufficient securing of the screws that connect the swing arm with the optics carrier.

Affected products