Leica recalls surgical microscopes with specific part numbers due to potential inaccurate illumination settings when used with BrightCare Plus Luxmeter, affecting surgical procedures.
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 certain surgical microscopes because a software adjustment issue with the illumination limits could lead to improper lighting during surgery. This affects the accuracy of the microscope's lighting when paired with a specific luxmeter device.
The photodiodes in the microscope's optics carrier have been altered, causing the software to miscalculate the illumination limits when used with the BrightCare Plus Luxmeter. This could lead to improper lighting settings during surgical procedures, potentially affecting visibility.
Surgical professionals using the recalled microscopes with BrightCare Plus Luxmeter may experience inaccurate lighting adjustments. The risk is low as the issue is software-related and does not cause immediate harm.
Check for part numbers a. 10448976 or b. 10448950 on the microscope. Serial numbers listed in the recall notice also identify affected units.
Identify the part number and serial number to confirm if your microscope is affected by this recall.
Leica discovered that a component change in the photodiodes causes inaccurate illumination adjustments when used with the BrightCare Plus Luxmeter.
No, the recall does not require immediate discontinuation. The issue is software-related and does not pose a serious injury risk.
Check for part numbers a. 10448976 or b. 10448950, and the specific serial numbers listed 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-1851-2022 — Leica Leica Hello, I own a Leica that is covered by recall Z-1851-2022 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
