Events

Recall of GE VIVID and LOGIQ Ultrasound Systems - Power Cord

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by GE Vingmed Ultrasound AS.

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
    22862
  • Event Initiated Date
    2018-04-26
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
  • Reason
    The manufacturer has identified that the system side of the power cord for certain vivid and logiq ultrasound systems may break and expose the electrical conductors leading to the risk of shock. this can lead to injuries up to and including cardiac arrhythmia or cardiac arrest.
  • Action
    Manufacturer to issue advice regarding use

Device

GE VIVID and LOGIQ Ultrasound Systems - Power Cord
  • Model / Serial
    Model: LOGIQ 9, LOGIQ E9, Vivid 7, Vivid E7, Vivid E9, Vivid E80, Vivid E90, and Vivid E95, Affected:
  • Manufacturer
    GE Vingmed Ultrasound AS

Manufacturer

GE Vingmed Ultrasound AS