Proteus XR/A General Purpose Radiographic System and Revolution XR/D Digital Radiographic System (2014-06-12)

Starting date:

June 12, 2014

Posting date:

July 3, 2014

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-40233

• 
  Reason
• 
  Affected products

Recalled Products

A) Proteus XR/A General Purpose Radiographic System

B) Revolution XR/D Digital Radiographic System

C) Proteus XR/A General Purpose Radiographic System

D) Revolution XR/D Digital Radiographic System

Reason

If a device is improperly re-installed, the collimator may not be properly seated and may loosen and fall. Such an event may occur immediately following re-installation during a service maintenance activity or may also occur a few months after a maintenance and continued use. A fall of a collimator while the system is in use could result in an injury to a patient or operator. There was a reported incident of a collimator fall which caused a serious patient injury.

Affected products