Leica Microsystems M530 Optics Carrier
Brand(s)
Last updated
Summary
Product
Leica Microsystems M530 Optics Carrier
Issue
Medical devices - Performance
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:
Alert / recall type
Health product recall
Category
Health products - Medical devices - 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
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