Leica Microsystems, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1848-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063

Product Classification:

Class II

Date Initiated: August 26, 2022

Date Posted: October 5, 2022

Recall Number: Z-1848-2022

Event ID: 90818

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.

Status: Ongoing

Product Quantity: 30 devices

Code Information:

Serial Numbers: 30622001, 41221001, 100522001, 50322001, 60522001, 11221001, 301121001, 20622001, 191121001, 91221001, 61221001, 81221001, 281121001, 291121001, 181121001, 300522001, 71221001, 20322001, 30322001, 60322001, 61221002, 21221001, 241121001, 101221001, 251121001, 31221001, 261121001, 91221002, 101221002, 51221001,

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated