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 neurosurgica
Hazard
The software issue described was corrected in the modification to the MXTTOUT controller parameter settings.
What You Should Do
Remedy
This is a retrospective report of a correction initiated on 05-Sept-2014. The software issue described was corrected in the modification to the MXTTOUT controller parameter settings. There were 8 affected devices at customer sites in the US. Field Service Technicians were deployed to the consignee locations to perform the system upgrade.
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Products
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 instru
- Brand
- Zimmer Biomet, Inc.
- UPC
- Serial #'s: RO10009, RO10011, RO10014, RO13023, RO13027, RO14031, RO14033 and RO14035
Units Affected
29 (8 US and 21 OUS)