Events

Recall of AW VOLUMESHARE 5 - CT APPLICATIONS

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
    47998
  • Event Risk Class
    III
  • Event Initiated Date
    2013-04-18
  • 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
    When performing a secondary capture generated from gsi viewer the header information is correct on the images. however when changing the roi (region of interest) and zooming in the dicom header does not change to reflect the new image thus the line measurements may be inaccurate.

Device

AW VOLUMESHARE 5 - CT APPLICATIONS

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)