Recall of GE Neuromuscular Transmission Module

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

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
  • Event ID
  • Event Initiated Date
  • Event Country
  • Event Source
  • Event Source URL
  • 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
    When the e-nmt-01 module is used in conjunction with the electrosensor, the neuromuscular transmission (nmt) values may indicate a deeper level of muscle relaxation than the actual level of muscle relaxation. in the clinical situation visual movements of the hand are seen after tof (train of four) stimulation, but the patient monitor shows no counts, or counts are not corresponding to the actual amount of movements. this issue may lead to an inadequate dose of muscle relaxants.
  • Action
    Product to be modified