FDA-Device2018-06-13Class II
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
MEDTECH SAS
Hazard
Replacement of units lacking an updated device approval.
Sold states
US Distribution
Affected count
29 units
Manufactured in
Parc Euromedecine Batiment 8, 1006 rue de la Croix Verte, Montpellier, N/A, France
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2108-2018Don't want to check this manually?
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