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