Events

Retiro De Equipo (Recall) de Xavant STIMPOD NMS410 / NMS450 Nerve Stimulator

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Xavant Technology.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    19771
  • Fecha de inicio del evento
    2016-02-16
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Recalling Organisation: Anatech Medical Ltd, P O Box 0171, 9 Pirihi Road, Takahiwai, Ruakaka, Whangarei
  • Causa
    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.
  • Acción
    Instructions for use to be updated

Device

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

Manufacturer

Xavant Technology