Health product recall

NEURO|MATE STEREOTACTIC SYSTEM (2020-10-12)

Starting date:
October 12, 2020
Posting date:
October 23, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-74159

Last updated: 2020-10-22

Affected Products

NEURO|MATE STEREOTACTIC SYSTEM

Reason

A problem has been detected relating to the Instructions for Use for Neuroinspire Neuromate Module (H-5630-3016 versions A2-A6) and the Plan Delivery USA Instructions for Use (H-5630-3050-A1). In Section 3.4 "Move to Trajectory" of the Instructions for Use, the bottom right image showing a negative offset is incorrect.

Affected products

NEURO|MATE STEREOTACTIC SYSTEM

Lot or serial number

All lots.

Model or catalog number

1.005

Companies
Manufacturer
Renishaw Mayfield Sarl
31 rue Ampere, Chassieu
Rhone
69680
FRANCE