Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ROSA(TM) Robotized Stereotactic Assistant Recalled by MEDTECH SAS Due to Replacement of units lacking an updated device approval.
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(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate.
Quantity: 29 units
Why Was This Recalled?
Replacement of units lacking an updated device approval.
Where Was This Sold?
US Distribution
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