MEDTECH SAS recalls ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Device is a computer-controlled electromechanical…

Recall date

May 8, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2108-2018

FDA classification

Class II

Brand / firm

MEDTECH SAS

Sold / distributed

US Distribution

Why it was recalled

Replacement of units lacking an updated device approval.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.