MEDTECH SAS recalls ROSA One 3.1 Brain Application software due to possible improper display of cross-sectional images during surgery planning, which could compromise patient safety.
Some cross-sectional images from the image acquisitions of the patients head may not be reconstructed/displayed properly in two and three dimension views when using ROSA Brain software, potentially compromising the surgery planning.
MEDTECH SAS is recalling the ROSA One 3.1 Brain Application software because some cross-sectional images of patients' heads may not display correctly in 2D or 3D views during surgery planning. This could lead to inaccurate surgical planning and potentially compromise patient safety.
The software may fail to properly reconstruct or display cross-sectional images of patients' heads in two and three dimensions. This could lead to incorrect surgical planning decisions, potentially compromising patient safety during brain surgery.
Surgical teams using the ROSA One 3.1 Brain Application software for brain surgery planning are likely affected. Patients undergoing brain surgery with this software version are at risk of inaccurate surgical planning.
Check for the specific serial numbers or UDI numbers listed: BS19037 through BS19058. The software version is ROSA One 3.1 Brain Application.
Verify if your software version is ROSA One 3.1 Brain Application by checking the serial number or UDI number on the device.
The software may not display cross-sectional images properly during surgery planning, which could lead to inaccurate surgical planning. However, the recall indicates this is a potential issue, not an immediate danger.
Check for the specific serial numbers or UDI numbers listed: BS19037 through BS19058. The software version is ROSA One 3.1 Brain Application.
The recall does not specify a remedy, so you should check the software version and contact MEDTECH SAS for further 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-1151-2020 — MEDTECH SAS MEDTECH SAS Hello, I own a MEDTECH SAS that is covered by recall Z-1151-2020 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.
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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.
