PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: June 13, 2018 Initiated: May 8, 2018 #Z-2108-2018

Product Description

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.

Reason for Recall

Replacement of units lacking an updated device approval.

Details

Recalling Firm
MEDTECH SAS
Units Affected
29 units
Distribution
US Distribution
Location
Montpellier, N/A

Frequently Asked Questions

What product 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.. Recalled by MEDTECH SAS. Units affected: 29 units.
Why was this product recalled? ▼
Replacement of units lacking an updated device approval.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 13, 2018. Severity: Moderate. Recall number: Z-2108-2018.

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