FDA recall Z-1850-2022

Product

Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737

Reason for recall

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.

Distribution

US Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2022-08-26

Report date

2022-10-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1850-2022