Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ROSA One 3.1 Brain Application Recalled by MEDTECH SAS Due to Some cross-sectional images from the image acquisitions of...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact MEDTECH SAS directly.
Affected Products
ROSA One 3.1 Brain Application
Quantity: 39 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About MEDTECH SAS
MEDTECH SAS has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report