Health product recall

ROSA One 3.1 Brain (2021-09-22)

Starting date:
September 22, 2021
Posting date:
September 28, 2021
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-76537

Last updated: 2021-09-28

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.

Affected products

ROSA One 3.1 Brain

Lot or serial number

BS18030
BS19042
BS19051
BS20105
BS21108
BS21151

Model or catalog number

ROSAS00216

Companies
Manufacturer
MEDTECH S.A
ZAC EUREKA
900 RUE DU MAS DE VERCHANT
MONPELLIER
34000
FRANCE