Device product
ROSA Surgical Device 2.5.8 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
Z-0184-2018
Product summary
- Event
- Event 78362
- Status
- Terminated
- Classification
- Class II
- Quantity
- 29 (8 US and 21 OUS)
- Official record key
device-enforcement:Z-0184-2018
Official wording
Reason: The software issue described was corrected in the modification to the MXTTOUT controller parameter settings.
Code information: Serial #'s: RO10009, RO10011, RO10014, RO13023, RO13027, RO14031, RO14033 and RO14035
Distribution pattern: Nationwide Distribution to AK, OH, TX, GA, and MI
Derived failure modes
-
Device software or design
software issue