FDA-Device2022-10-05Class II
Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737
Leica Microsystems, Inc.
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.
Sold states
US Nationwide distribution.
Affected count
115 devices
Manufactured in
10 Parkway North blvd ste 300, N/A, deerfield, IL, United States
Products
Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1850-2022Don't want to check this manually?
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