Recall Z-0167-2018 ยท HAW Neurological Stereotaxic Instrument
Zimmer Biomet, Inc.
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.
| Date | Jul 20, 2016 |
| Status | Terminated |
| Reason | Communication errors between ROSANNA BRAIN software, MARIO software and the Stubli CS8C controller. |
| Root cause | Software design |
| Action | This is a retrospective report of a correction initiated on 20-Jul-2016. Customers were informed onsite by field Service Technicians of the planned correction. The software issue described was corrected in the new software version ROSA Brain 3.0.0.20. Field Service Technicians were deployed to the customers locations to perform the system upgrade. . |
| Quantity | 18 (14 US and 4 OUS) |
| Distribution | Worldwide Distribution - US Nationwide in the states of OH, FL, MA, MN, DC, NC, CA, NY, PA and countries of Australia and France |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151359 | ROSA Brain Medtech S.A, Dec 18, 2015 |