Events

Recall of AW VOLUMESHARE 4 - THORACIC VCAR

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
    91725
  • Event Risk Class
    II
  • Event Initiated Date
    2011-05-06
  • 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 using the summary table feature on thoracic vcar to display data incorrect patient name will be displayed if the user does not exit the application in between the analysis of two consecutive patients. if the user did not exit the application the correct imaging study will appear and the data on the summary table will contain the results of the current patient imaging study however the previous patient name will be displayed on the summary table. this summary result may be separated from the remainder of the ct imaging exam if it is printed on film or paper and incorrectly inserted in another patient's file. this issue may cause confusion and possible incorrect assessment. no adverse event has been reported related to this issue.

Device

AW VOLUMESHARE 4 - THORACIC VCAR

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)