Events

Recall of AW VOLUMESHARE 4 - SOFTWARE OPTIONS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by GE HEALTHCARE CANADA INC..

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
    93533
  • Event Risk Class
    II
  • Event Initiated Date
    2011-05-31
  • 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 seno advantage workstation is synchronized with radiology information system (ris) using clinical context object workgroup (ccow) (an hl7 standard protocol designed to enable disparate applications to synchronize in real-time) the following issues could occur: 1. two different patient images may be displayed at the same time. the seno advantage workstation may display one patient's multi-modality images on the 1 megapixel (landscape) color monitor and another patient's mammography images on the 5 megapixel (portrait) high-resolution black and white monitors. the patient name annotation is correct whenever it is displayed on any monitor. 2. the patient images displayed on the seno advantage high-resolution black and white monitors may not show images of the patient selected on ris and on the seno advantage color monitor. the patient name annotation is correct whenever it is displayed on any monitor.

Device

AW VOLUMESHARE 4 - SOFTWARE OPTIONS
  • Model / Serial
    Model Catalog: 5342425-X (Lot serial: ); Model Catalog: 5183685-X (Lot serial: )
  • Product Description
    Seno Advantage 2.2 Volumeshare 2/4
  • Manufacturer
    GE HEALTHCARE CANADA INC.

Manufacturer

GE HEALTHCARE CANADA INC.