Events

Recall of 3.0T GEMflex Coil from NeoCoil

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by NeoCoil 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
    19753
  • Event Initiated Date
    2016-02-12
  • 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
    Manufacturer has advised that part of the cable assembly may overheat when the device is used. rarely, this could result in minor burn injury in case of prolonged direct skin contact with the overheating part.
  • Action
    Manufacturer to issue advice regarding use

Device

3.0T GEMflex Coil from NeoCoil
  • Model / Serial
    Model: 5430008-2, 5430008-3, 5430008-4 and 5430008-5, Affected:
  • Manufacturer
    NeoCoil LLC

Manufacturer

NeoCoil LLC