Events

Angiodynamics Accu2i pMTA Applicator- Hyperthermia system applicator 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 AngioDynamics Inc (US) 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
    21545
  • 사례 시작날짜
    2017-06-15
  • 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: Getz Healthcare Limited, 2/20 Beatrice Tinsley Crescent, Albany, Auckland
  • 원인
    Manufacturer is recalling the accu2i pmta hyeprthermia system applicator as a potential failure mode has been identified of the tubing coolant line developing a leak within the applicator system which causes a "high reflected power" fault condition that makes the applicator inoperable to deliver microwave energy., hazard 1: applicator will not deliver power due to high reflected power fault condition., hazard 2: applicator's cooling line leaks cooling fluid within the applicator shaft., while the specific failure mode of the applicator not delivering the desired microwave energy would not result in any direct harm, the inserted applicator would need to be removed.
  • 조치
    Product to be returned to supplier

Device

Angiodynamics Accu2i pMTA Applicator- Hyperthermia system applicator
  • 모델명 / 제조번호(시리얼번호)
    Model: 900-600; 900-601; 900-602, Affected: Various Lot numbers
  • Manufacturer
    AngioDynamics Inc (US)

Manufacturer

AngioDynamics Inc (US)