Events

Recall of GE Advantx and Innova Cardiovascular X-ray System

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

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
    15260
  • Event Initiated Date
    2013-08-22
  • 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 the potential for the 4 outer screws that hold the overhead video monitor suspension to the carriage to be missing. missing screws may increase the risk for fall of the monitor suspension.
  • Action
    Product to be modified

Device

GE Advantx and Innova Cardiovascular X-ray System
  • Model / Serial
    Model: Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ, Affected: Systems equiped with video monitor suspension
  • Manufacturer
    GE Medical Systems SCS

Manufacturer

GE Medical Systems SCS