Leica recalls M530 OHX 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 certain M530 OHX surgical microscopes that may have inaccurate illumination adjustments when used with the BrightCare Plus Luxmeter software. This could lead to improper lighting settings during surgery, potentially affecting surgical precision.
The photodiodes inside the microscope's optics carrier have been modified, causing the software to adjust illumination limits inaccurately when paired with the BrightCare Plus Luxmeter. This could result in incorrect lighting levels during surgery, potentially affecting surgical precision but not causing immediate injury.
Surgical staff using Leica M530 OHX microscopes with specific serial numbers listed in the recall. Surgeons and medical professionals are most at risk if the software adjustment error impacts surgical lighting.
Check if your microscope has the part number 10448737 and the serial numbers listed in the recall notice. The affected models are Leica M530 OHX surgical operating microscopes.
Verify your microscope's serial number against the list provided in the recall notice to confirm if it is affected.
Leica discovered during internal testing that a component change in the photodiodes causes inaccurate illumination adjustments when used with BrightCare Plus Luxmeter software.
Check if your microscope has the part number 10448737 and a serial number from the list provided in the recall notice.
The recall does not include a remedy, so you should check the product details to confirm if your microscope is affected and contact Leica for further guidance.
We’ve drafted a message you can send Leica to request your refund or repair — edit it as you like.
Subject: Recall Z-1850-2022 — Leica Leica Hello, I own a Leica that is covered by recall Z-1850-2022 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.
