Events

Recall of StimPod NMS 450 Nerve Stimulator

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

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
    16612
  • Event Initiated Date
    2014-05-02
  • 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: Anatech Medical Ltd, P O Box 0171, 9 Pirihi Road, Takahiwai, Ruakaka, Whangarei
  • Reason
    In isolated incidences (less than 0.003%) 0 while using the device in nmba monitoring mode, electrodes used may deteriorate to a level where current densities may be large enough to cause superficial burns on the skin of the patient. the occurrence of this phenomena is due to a lack of training on the impedance monitoring fucntion of the device and it is imperative that users are properly trained to monitor the impedance of the electrode/skin impedance through the actual current delivered function in mnba with all stmpof nms450s.
  • Action
    Instructions for use to be updated

Device

StimPod NMS 450 Nerve Stimulator
  • Model / Serial
    Model: XT-45011, XT-45011-NA, XT-45001 and XT-45001-NA, Affected:
  • Manufacturer
    Xavant Technology

Manufacturer

Xavant Technology