Mazor Robotics recalls MAZOR X robotic guidance systems with software versions 4.2.2 or 5.0.1 due to a software update issue. Affected units include specific GTINs and serial numbers listed in the recall notice.
Software update
Mazor Robotics is recalling its MAZOR X robotic guidance systems with software versions 4.2.2 or 5.0.1. This recall is due to a software update that may cause system instability. Users should check their device details to see if they are affected.
The software update may cause system instability, but the recall does not specify a risk of injury or serious harm. The hazard is related to software updates rather than physical safety issues.
Users of the MAZOR X robotic guidance system with specific software versions and serial numbers listed in the recall notice are affected. Surgeons and medical professionals who use this system are most at risk.
Check if your MAZOR X system has software versions 4.2.2 or 5.0.1. Affected units include specific GTINs and serial numbers listed in the recall notice.
Verify your device's software version by checking the device settings or documentation.
No, the recall does not require immediate discontinuation. Check your software version to see if you are affected.
The recall does not specify a remedy, so contact Mazor Robotics directly for further instructions.
Check your device's software version and compare it to the affected versions (4.2.2 or 5.0.1) listed in the recall notice.
We’ve drafted a message you can send Mazor Robotics to request your refund or repair — edit it as you like.
Subject: Recall Z-0101-2024 — Mazor Robotics Mazor Robotics Hello, I own a Mazor Robotics that is covered by recall Z-0101-2024 from Mazor Robotics. 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.