Events

Recall of MRI system, full-body, superconducting magnet

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by GE Healthcare Tianjin Company Ltd.

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
    20650
  • Event Initiated Date
    2016-09-19
  • 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 become aware of an issue with incorrect rf power monitor function with the signa creator and signa explorer., if the rf amplifier output power exceeds the predicted sar (specific absorption rate) amount, the rf power monitor will stop the scan. this would prevent the power monitor from detecting any subsequent failure of rf transmit function.
  • Action
    Software to be upgraded

Device

MRI system, full-body, superconducting magnet

Manufacturer

GE Healthcare Tianjin Company Ltd