Leica recalls Arveo surgical microscopes with specific serial numbers due to potential inaccurate illumination adjustments when used with BrightCare Plus 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 surgical microscopes with certain serial numbers because a component change in the photodiodes may cause inaccurate illumination adjustments when used with the BrightCare Plus Luxmeter software. This could affect surgical procedures by causing improper lighting levels.
The photodiode component change can cause the software to adjust illumination limits inaccurately when the BrightCare Plus Luxmeter is used. This may lead to improper lighting levels during surgery, potentially affecting procedure accuracy.
Surgical professionals using the Arveo microscopes with specific serial numbers are most at risk. The recall affects devices sold in the U.S. with the listed serial numbers.
Check if your Leica Arveo surgical microscope has a serial number listed in the provided list: 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.
Verify your microscope's serial number against the list provided in the recall notice.
Leica discovered a component change in the photodiodes that may cause inaccurate illumination adjustments when used with the BrightCare Plus Luxmeter software.
Check your serial number against the list provided; if it matches, contact Leica for further instructions.
The recall notice does not specify a remedy, so no immediate fix is provided.
We’ve drafted a message you can send Leica to request your refund or repair — edit it as you like.
Subject: Recall Z-1849-2022 — Leica Leica Hello, I own a Leica that is covered by recall Z-1849-2022 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.
