Events

Recall of VOLUSON E8 ULTRASOUND SYSTEM - MAIN UNIT

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
    17766
  • Event Risk Class
    II
  • Event Initiated Date
    2007-09-28
  • 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 a spectrum of a pulsed wave doppler that shows an angle correction unequal 0 is reloaded from archive or sent to a dicom destination this angle correction is mistakenly disregarded.

Device

VOLUSON E8 ULTRASOUND SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: H48651PT (Lot serial: D00371 D00390); Model Catalog: H48651PT (Lot serial: D00229 D00329 D00370); Model Catalog: H48651PT (Lot serial: S/N D00161 D00162 D00164)
  • Product Description
    VOLUSION E8 ULTRASOUND SYSTEM
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)