M320 Surgical Microscope (2018-05-18)

Starting date:

May 18, 2018

Posting date:

June 14, 2018

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-67038

• Reason
• Affected products

Affected products

M320 Surgical Microscope

Reason

Three (3) complaints were reported involving mechanical part failures for the Leica M320 Microscope System. These specific systems had failures with the screws that hold the gas spring fixation bracket in place. Due to this failure, the gas spring, which is fixed to the upper part of the parallelogram, cannot hold up the weight of the optics carrier. This may potentially cause the M320 optics carrier to drop to the lower mechanical end stop. This failure has been linked to an identified batch of non-conforming screws.

Affected products