Leica Microsystems recalls M530 OHX surgical microscopes with serial numbers listed; overheating risk may cause unexpected shutdowns. Affected units should be checked for serial numbers.
There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Consequently, due to the overstressing of the internal components, one specific component can fail which will cause the device to unexpectedly shutdown.
Leica Microsystems is recalling its M530 OHX surgical microscope systems due to a potential overheating issue that could cause unexpected shutdowns. This risk affects medical professionals using the device during procedures.
The microscope's power supply may overheat because internal components are overstressing. This can cause a specific component to fail, leading to the device shutting down unexpectedly during use.
Medical professionals using the Leica M530 OHX surgical microscope systems are most at risk. Patients undergoing surgery with this device may be affected if the system unexpectedly shuts down.
Check the serial number on your Leica M530 OHX microscope. Affected units have serial numbers listed in the recall notice (e.g., 10622001, 10622002, etc.).
Look for the serial number on your Leica M530 OHX microscope to confirm if it's affected.
The power supply may overheat due to internal component overstressing, which can cause unexpected shutdowns during use.
Check the serial number against the list provided in the recall notice to see if your unit is affected.
The recall notice does not specify a remedy, so no action is required beyond checking if your unit is affected.
We’ve drafted a message you can send Leica to request your refund or repair — edit it as you like.
Subject: Recall Z-0477-2023 — Leica Leica Hello, I own a Leica that is covered by recall Z-0477-2023 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.
