Events

Recall of GE Magnetic Resonance Imaging Systems

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 LLC.

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
    16485
  • Event Initiated Date
    2014-04-03
  • 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
    Gradient coil electromechanical connections may loosen causing an increase in resistance. the increased resistance can lead to increasing heat during scanning which, in turn, can cause material in the rear endbell enclosure to overheat, generate smoke in the scan room, and cause some localized melting of the endbell. this overheating has occurred only while units were being serviced by ge service engineers during repeated evaluation scanning. however, the issue could also occur in clinical mode.
  • Action
    Product to be modified

Device

GE Magnetic Resonance Imaging Systems
  • Model / Serial
    Model: Models: : Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discovery MR750w, and Discovery MR750w GEM products, Affected:
  • Manufacturer
    GE Medical Systems LLC

Manufacturer

GE Medical Systems LLC