Events

Recall of AW SERVER

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
    86954
  • Event Risk Class
    II
  • Event Initiated Date
    2011-11-03
  • 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
    Issue #1 (volume viewer): on monitors with 2 megapixel (2mp) resolution and higher (i.E. higher than 1600x1200 resolution) for a certain sequence of user commands switching between two volume viewer tabs with different patients the topmost strip of the volume viewer display fails to update between patients. this causes the incorrect (i.E. first) patient name to display in the topmost viewports when the second patient's image data is displayed. the lower viewports display the correct patient name as does the patient name tab. issue #2 (results viewer): on aw server the results viewer application may take 5-8 seconds to initialize and display a selected patient exam when first started. if a second patient exam is selected before this initialization has completed the second patient's data will be displayed in the viewports with the corresponding patient name on the viewports. however the first patient's name will be displayed on the applications tab.

Device

AW SERVER

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)