Events

Xavant STIMPOD NMS410 / NMS450 Nerve Stimulator 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Xavant Technology 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    19771
  • 사례 시작날짜
    2016-02-16
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Recalling Organisation: Anatech Medical Ltd, P O Box 0171, 9 Pirihi Road, Takahiwai, Ruakaka, Whangarei
  • 원인
    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.
  • 조치
    Instructions for use to be updated

Device

Xavant STIMPOD NMS410 / NMS450 Nerve Stimulator
  • 모델명 / 제조번호(시리얼번호)
    Model: XT-41000, XT-41000-NA, XT-41001, XT-41001-NA, XT-45011,, Affected:
  • Manufacturer
    Xavant Technology

Manufacturer

Xavant Technology