ExacTrac Patient Positioning System (2018-01-25)

Starting date:

January 25, 2018

Posting date:

February 16, 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-66012

• 
  Reason
• 
  Affected products

Affected products

1. ExacTrac Patient Positioning System - ExacTrac 6.0 X-Ray Positioning Software
2. ExacTrac Patient Positioning System - ExacTrac Software

Reason

The usage of workflows that deviate from the recommended specifications in the user manual for ExacTrac Patient Positioning System (v. 6.0, 6.1, 6.2, and 6.5) with Auxiliary Device Interface (ADI) and Varian Clinac or Varian Truebeam, may result in misinterpretation of beam authorization via ADI.

Affected products