Z-1851-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 5, 2022
- Initiation Date
- August 26, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32 devices
Product Description
Leica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. 10448950
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 Pattern
US Nationwide distribution.
Code Information
a. 10448976, Serial Numbers: 120322001, 300122001, 170921001, 301221001, 40122001, 140522001, 151221002, 301021002, 81221002, 100222002, 40222002, 220821001, 300122002, 110322001, 50322001, 180921001, 260821001, 90622001, 120422001, 100522001, 90522001, 210821001, 250122001, 301021001, 100222001; b. 10448950, Serial Numbers: 160222001, 90721001, 50422001, 50422002, 91221001, 160921001, 61221001