Health product recall

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

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

M320 Surgical Microscope

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

10448419

10448420

10448485

10448486

Companies
Manufacturer

Leica Microsystems (Schweiz) Ag

Max Schmidheiny-Strasse 201

Heerbrugg

9435

SWITZERLAND