Leica recalls ARveo 8 surgical microscopes with specific serial numbers due to potential inaccurate illumination adjustment when using BrightCare Plus with Luxmeter software.
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.
Leica is recalling ARveo 8 surgical microscopes with certain serial numbers because a component change in the photodiodes may cause inaccurate illumination adjustments when used with BrightCare Plus software. This could affect surgical procedures by causing improper lighting levels.
The photodiodes in the microscope's M530 Optics Carrier have been changed, which can cause the software to adjust illumination limits inaccurately when paired with BrightCare Plus and Luxmeter. This may lead to improper lighting during surgical procedures but does not cause immediate injury.
Surgical professionals using Leica ARveo 8 microscopes with the listed serial numbers are affected. The risk is low as the issue only impacts illumination accuracy during specific software use, not causing immediate harm.
Check if your Leica ARveo 8 microscope has a serial number from the list provided: 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.
Verify your microscope's serial number against the list provided in the recall notice.
Leica has identified a component change in the photodiodes that may cause inaccurate illumination adjustments when used with BrightCare Plus software.
No, the recall does not require immediate discontinuation. The issue only affects illumination accuracy during specific software use.
Check your serial number against the list of affected numbers provided in the recall notice.
We’ve drafted a message you can send Leica to request your refund or repair — edit it as you like.
Subject: Recall Z-1848-2022 — Leica Leica Hello, I own a Leica that is covered by recall Z-1848-2022 from Leica. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
