Reported Jun 13, 2018 · Terminated

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

Medtech Sas

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: MEDTECH SAS · Parc Euromedecine Batiment 8 · Montpellier, N/A · N/A

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.

Lot codes and dates: Serial Numbers
RO 10 009
RO 10 011
RO 10 014
RO 13 023
RO 13 027
RO 14 031
RO 14 033
RO 14 035
RO 14 038
RO 14 039
RO 14 040
RO 14 041
RO 14 043
RO 15 044
RO 15 045
RO 15 046
RO 15 050
RO 15 051
RO 15 052
RO 15 053
RO 15 054
RO 15 058
RO 15 059
RO 15 060
RO 15 061
RO 15 063
RO 15 064
RO 15 067
RO 15 069
Amount recalled: 29 units

Replacement of units lacking an updated device approval.

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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