Z-1849-2022 Class II Ongoing

Recalled by Leica Microsystems, Inc. — deerfield, IL

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
25 devices

Product Description

Leica Surgical Operating Microscopes, Arveo, Part Number 10448999

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

Serial Numbers: 210721001, 180721001, 190721001, 121021001, 100821001, 60821001, 90821001, 120821001, 10821001, 80721001, 40821001, 130821001, 290821001, 240821001, 91021001, 180921001, 181121001, 151021001, 190821001, 160921001, 20721001, 50721001, 40921001, 150821001, 160821001