Leica Microsystems, Inc. recalls Leica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. 10448950
- Recall date
- August 26, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1851-2022
- FDA classification
- Class II
- Brand / firm
- Leica Microsystems, Inc.
- Sold / distributed
- US Nationwide distribution.
Why it was recalled
During internal testing, Leica Microsystems has become aware of a component change on the photodiodes inside the M530 Optics Carrier which will result in an inaccurate adjustment of the illumination limits by the software of the surgical microscope when "BrightCare Plus" with Luxmeter is used.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Leica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. 10448950
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