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Leica Microsystems, Inc. recalls Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737
Recalled October 5, 2022 · FDA recall Z-1850-2022 · Leica Microsystems
Hazard
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. · FDA Class II
Units
115 devices
Sold at
US Nationwide distribution.
Description
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.
Product
Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737
Manufacturer(s)
Leica Microsystems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →