Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
ROSA One 3.1 Brain application The device is intended for Recalled by MEDTECH SAS Due to The firm has become aware of a software...
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 The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained surgeons to guide standard surgical instruments during brain and spine surgeries.
Quantity: 119 (US); 55 (OUS)
Why Was This Recalled?
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.
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