MEDTECH SAS recalls ROSA One 3.1 Brain application software due to potential inaccurate electrode placement during brain surgery, risking serious injury or death. Affected units have specific serial numbers.
The firm has become aware of a software anomaly affecting ROSA One 3.1 Brain application which led to the inaccurate placement of an electrode during surgery. The firm has received 3 global complaints related to the issue. An incorrect trajectory could result in serious injury or death if undetected during surgery.
MEDTECH SAS is recalling the ROSA One 3.1 Brain application software for brain surgery tools because a software error could cause incorrect electrode placement during surgery, potentially leading to serious injury or death. This recall follows three global complaints about the issue.
The software anomaly in ROSA One 3.1 Brain can cause inaccurate placement of an electrode during surgery. If undetected, this incorrect trajectory could lead to serious injury or death due to the critical nature of brain surgery.
Trained surgeons using the ROSA One 3.1 Brain application for brain and spine surgeries are most at risk. The recall affects specific serial numbers of the software version.
Check if your ROSA One 3.1 Brain application software has a serial number listed in the provided range (US and OUS serial numbers are detailed in the recall notice).
Verify your ROSA One 3.1 Brain application software version matches the affected serial numbers listed in the recall.
Yes, the software anomaly could cause inaccurate electrode placement during surgery, potentially leading to serious injury or death if undetected.
The recall includes 42 specific serial numbers for US and OUS models.
Check if your software has a serial number in the provided list. If affected, contact MEDTECH SAS for guidance.
We’ve drafted a message you can send MEDTECH SAS to request your refund or repair — edit it as you like.
Subject: Recall Z-0118-2022 — MEDTECH SAS MEDTECH SAS Hello, I own a MEDTECH SAS that is covered by recall Z-0118-2022 from MEDTECH SAS. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
