MEDTECH SAS recalls ROSA Brain 3.0 Application-Brain software with specific serial numbers due to potential image reconstruction errors that could compromise surgery planning. Affected units include 70 serial numbers listed in the recall notice.
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 specific versions of their ROSA Brain 3.0 Application-Brain software because some cross-sectional images from patient head scans may not display correctly in 2D or 3D views during surgery planning. This could lead to inaccurate surgical planning if the software fails to properly reconstruct images.
The software may fail to correctly reconstruct and display cross-sectional images from patient head scans when viewed in two or three dimensions. This could lead to inaccurate surgical planning if the images are not properly visualized during the planning phase.
Surgical teams using the recalled ROSA Brain 3.0 Application-Brain software for patient head imaging. The risk is primarily for medical professionals who rely on this software for precise surgical planning.
Check if your ROSA Brain 3.0 Application-Brain software has one of the 70 listed serial numbers. The recall includes specific serial numbers and their corresponding UDI codes as detailed in the notice.
Verify your software version matches the recalled ROSA Brain 3.0 Application-Brain version with the listed serial numbers.
The recall specifically addresses potential image reconstruction errors in the software that could compromise surgery planning. If you have the recalled software version, you should check the serial numbers listed in the recall notice.
Check if your ROSA Brain 3.0 Application-Brain software has one of the 70 specific serial numbers listed in the recall notice.
The recall does not specify a remedy, so you should check the software version and serial number against the list provided. If affected, 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-1150-2020 — MEDTECH SAS MEDTECH SAS Hello, I own a MEDTECH SAS that is covered by recall Z-1150-2020 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.
