Events

Recall of IMAGE PASTING PATIENT BARRIER

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
    132271
  • Event Risk Class
    II
  • Event Initiated Date
    2011-10-19
  • 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 a potential issue associated with the patient barrier rotating arm that is a part of the definium 8000 and discovery xr650 image pasting systems that may impact patient and/or user safety. the patient barrier rotating arms that are used to position and stabilize the patient during image pasting procedures may fail to retain residual friction at the arm pivot. this could permit the arm to swing freely when the rotating arm locking lever is released. should this happen during use injury to the patient and/or user could occur.

Device

IMAGE PASTING PATIENT BARRIER

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)