BrightMatter Guide (2018-10-08)

Starting date:
October 8, 2018
Posting date:
October 26, 2018
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-68100

Affected products

BrightMatter Guide

Reason

A software defect related to 3rd-party port navigation in BrightMatter Guide 1.5 System was discovered on synaptive premises through routine internal testing on September 20th, 2018.  While the likelihood of potential serious health consequences is remote, the use of the defective system can result in serious injury and/or death.

Affected products

BrightMatter Guide

Lot or serial number
  • 00634DBD062
Model or catalog number
  • SYN-0027
Companies
Manufacturer
Synaptive Medical Inc.
555 Richmond Street West, Suite 800
Toronto
M5V 3B1
Ontario
CANADA