ROSA One 3.1 Brain (2021-09-22)Health ProductsSep 22nd, 2021 @ 12:00 AM
Basic Details
Issue: Medical Devices
Category: Medical Device
Audience: General Public, Healthcare Professionals, Hospitals
Department: Health Canada
Hazard classification: Type I
Alert type: Medical Device Recall
Products
| Lot or serial number | Brand name | Companies | Model or catalog number |
|---|---|---|---|
| BS18030 | ROSA One 3.1 Brain |
| ROSAS00216 |
Introduction
Affected Products
ROSA One 3.1 Brain
Reason
Medtech s.A - zimmer biomet is initiating a medical device correction for rosa one 3.1 Brain application products. The affected software version was implemented in rosa one 3.1 Units beginning in december 2019.
The rosa one 3.1 Brain application system is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained 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 neurosurgery may be appropriate.
Description of the issue:
medtech s.A - zimmer biomet has become aware of an event where a software anomaly affecting rosa one 3.1 Brain application led to the inaccurate placement of an electrode during a surgery. Since the installation of the impacted software beginning in december 2019, there has been three global complaints related to the software anomaly out of approximately 3,600 surgeries performed. While patient injury has not been reported, an incorrect trajectory could result in serious injury or death if it goes undetected during surgery.
The rosa one 3.1 Brain application system is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained 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 neurosurgery may be appropriate.
Description of the issue:
medtech s.A - zimmer biomet has become aware of an event where a software anomaly affecting rosa one 3.1 Brain application led to the inaccurate placement of an electrode during a surgery. Since the installation of the impacted software beginning in december 2019, there has been three global complaints related to the software anomaly out of approximately 3,600 surgeries performed. While patient injury has not been reported, an incorrect trajectory could result in serious injury or death if it goes undetected during surgery.
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