Events

Recall of AW VOLUMESHARE2 - SOFTWARE OPTIONS

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
    102213
  • Event Risk Class
    II
  • Event Initiated Date
    2009-07-16
  • 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
    Measurement values provided by seno advantage workstations 1x 2.0 & 2.1 may be incorrect when applied to magnification images acquired on non-ge digital mammography systems which could lead to overestimate of size of breast lesion.

Device

AW VOLUMESHARE2 - SOFTWARE OPTIONS
  • Model / Serial
    Model Catalog: 5183859-4 (Lot serial: 8354008); Model Catalog: 5183859-3 (Lot serial: 8354008); Model Catalog: 5183859-5 (Lot serial: 9093001 A7274009 M8281004); Model Catalog: 5183859-4 (Lot serial: 9093001 A7274009 M8281004); Model Catalog: 5183859-5 (Lot serial: S/N'S A8177079 A9062007); Model Catalog: 5183859-4 (Lot serial: S/N'S A8177079 A9062007); Model Catalog: 5183859-5 (Lot serial: 8354008); Model Catalog: S30321ZK (Lot serial: >10 NUMBERS); Model Catalog: S30321ZK (Lot serial: CONTACT); Model Catalog: S30321ZK (Lot serial: MANUFACTURER); Model Catalog: 5183859-3 (Lot serial: S/N'S A8177079 A9062007); Model Catalog: 5183859-3 (Lot serial: 9093001 A7274009 M8281004)
  • Product Description
    AW VOLUMESHARE2
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)