Events

Rappel de Xavant STIMPOD NMS410 / NMS450 Nerve Stimulator

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Xavant Technology.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    19771
  • Date de mise en oeuvre de l'événement
    2016-02-16
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Recalling Organisation: Anatech Medical Ltd, P O Box 0171, 9 Pirihi Road, Takahiwai, Ruakaka, Whangarei
  • Cause
    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
  • Modèle / numéro de série
    Model: XT-41000, XT-41000-NA, XT-41001, XT-41001-NA, XT-45011,, Affected:
  • Manufacturer
    Xavant Technology

Manufacturer

Xavant Technology