Health product recall

Leica Microsystems M530 Optics Carrier

Last updated

Summary

Product
Leica Microsystems M530 Optics Carrier
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Leica Microsystems M530 Optics Carrier

190122003
191121006
11221001
140222002
60422002
70422001

10448737
10448704

Issue

During internal testing Leica Microsystems has become aware of a component change on the photodiodes inside the M530 Optics Carrier. The photodiodes are used as luxmeters to optimize the "brightcare plus" limit which is calculated based on real-time light intensity data to compensate for decreased light intensity as bulbs age. The component change of the photodiode will result in an inaccurate adjustment of the illumination limits.

Recall start date: August 12, 2022

Additional information

Details
Original published date: 2022-09-26
Alert / recall type
Health product recall
Category
Health product - Medical device - Ear, nose and throat
Companies

Leica Microsystems (Schweiz) Ag

Max Schmidheiny-Strasse 201, Heerbrugg, St. Gallen, Switzerland, 9435

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-64566