Leica Microsystems recalls Proveo 8 surgical microscope systems with specific serial numbers due to potential overheating causing unexpected shutdowns.
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 is recalling Proveo 8 surgical microscope systems with certain serial numbers because internal components may overheat, causing the device to shut down unexpectedly. This could disrupt surgical procedures if the microscope is in use during an operation.
The microscope's power supply may overheat because internal components are overstressing. This can cause the device to shut down unexpectedly during use, potentially disrupting critical surgical procedures.
Surgical professionals using the Proveo 8 microscope system with the listed serial numbers are most at risk. Patients undergoing surgery with this equipment may face interruptions in their procedure.
Check the serial number on your Proveo 8 microscope. Affected units have specific serial numbers listed in the recall notice, including those added through an expansion on September 8, 2023.
Look for the serial number on your Proveo 8 microscope to determine if it's affected by this recall.
Reach out to Leica Microsystems for guidance on next steps if your unit is affected.
The power supply may overheat due to internal component overstressing, causing unexpected shutdowns during use.
Check the serial number against the list provided in the recall notice, which includes specific numbers added through an expansion on September 8, 2023.
Contact Leica Microsystems for guidance on next steps 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-0475-2023 — Leica Leica Hello, I own a Leica that is covered by recall Z-0475-2023 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.
