FDA-Device2017-09-20Class II
Herga foot switch, model 6289-WS, a component of the ROSA Robotized Stereotactic Assistant Surgical Device, Model 2.5.8. The firm name on the foot switch label is Herga Electric Limited, Bury, St. Edmunds, Suffolk IP32 6NN. 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
Zimmer Biomet, Inc.
Hazard
Complaints were received reporting the system would freeze/shut down while in Fulgurate mode.
Sold states
Worldwide Distribution - US (nationwide) and Internationally to Canada, China, France, Germany, India, Israel, Italy, Russia, Saudi Arabia, Spain and the United Kingdom.
Affected count
64 devices
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
Herga foot switch, model 6289-WS, a component of the ROSA Robotized Stereotactic Assistant Surgical Device, Model 2.5.8. The firm name on the foot switch label is Herga Electric Limited, Bury, St. Edmunds, Suffolk IP32 6NN. 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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3117-2017Don't want to check this manually?
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