Events

Recall of AW VOLUMESHARE 4 - SENO ADVANTAGE SOFTWARE OPTION

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
    144607
  • Event Risk Class
    III
  • Event Initiated Date
    2012-09-13
  • 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 that patient mismatch without a warning message could occur on seno advantage (sa) workstations under the following circumstances: 1. new non-mammographic images for patient a are being received (for example via the network) at the same time that mammographic images for patient a are displayed on the high-resolution black and white monitors. 2. the non-mammographic images are then selected and displayed on the color monitor. 3. mammographic images from a different patient are then selected on the high-resolution black and white monitors.

Device

AW VOLUMESHARE 4 - SENO ADVANTAGE SOFTWARE OPTION
  • Model / Serial
    Model Catalog: 5341143-X (Lot serial: 000004410002GS); Model Catalog: 5183685-X (Lot serial: >10 lot numbers contact mfg); Model Catalog: 5183859-X (Lot serial: >10 lot numbers contact mfg); Model Catalog: 5342425-X (Lot serial: 00000193277GE1)
  • Product Description
    AW VOLUMESHARE - SENO ADVANTAGE SOFTWARE OPTION
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)