Events

Recall of Xavant STIMPOD NMS410 / NMS450 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
    19771
  • Event Initiated Date
    2016-02-16
  • 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
    Fsn concerning an update of the instruction for use (ifu), which includes changes to the sections warnings, and introduces instructions to the user to aid in the safe and precise use of the medical device., 1. inspect all parts for any damage or manipulation. never use any damaged or manipulated part!, 2. if an electrically conductive surface of the stimpod device or its cables is exposed, such electrically conductive surface may shock a person handling it. do not use such a device or accessory, please contact the manufacturer for repair., 3. the refractory period delay is set at a default value to prevent the user from repeating stimulation while the nerve synapse is recovering from effects of the previous stimulation as per example: a refractory period of less than 12 seconds in tof mode is not advisable as measurements might not represent the effect of blocking agents on the neuromuscular junction.
  • Action
    Instructions for use to be updated

Device

Xavant STIMPOD NMS410 / NMS450 Nerve Stimulator
  • Model / Serial
    Model: XT-41000, XT-41000-NA, XT-41001, XT-41001-NA, XT-45011,, Affected:
  • Manufacturer
    Xavant Technology

Manufacturer

Xavant Technology