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

• 
  Reason
• 
  Affected products

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