Events

Recall of VMX MOBILE X-RAY SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE).

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    63322
  • Event Risk Class
    II
  • Event Initiated Date
    2012-01-16
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Ge healthcare has become aware of an issue associated with the base casting for the articulated arm of the vmx and vmx plus mobile x-ray systems that may impact operator or patient safety. the casting which retains the articulated arm to the base of the vmx may develop fatigue cracks through long term use of the product. if the casting develops cracks of significant size the articulated arm may no longer be properly secured to the base of the vmx. the loss of retention may permit the articulated arm x-ray tube and collimator to fall in an uncontrolled manner. the fall of this object may create a hazard to operators and patients during transport or use of the equipment.

Device

VMX MOBILE X-RAY SYSTEM

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)