FDA-Device2017-11-29Class II
ROSA Brain 3.0.0 Usage: The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be appropriate.
Zimmer Biomet, Inc.
Hazard
Communication errors between ROSANNA BRAIN software, MARIO software and the St¿ubli CS8C controller.
Sold states
Worldwide Distribution - US Nationwide in the states of OH, FL, MA, MN, DC, NC, CA, NY, PA and countries of Australia and France
Affected count
18 (14 US and 4 OUS)
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
ROSA Brain 3.0.0 Usage: The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be appropriate.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0167-2018Don't want to check this manually?
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