Events

Nortec patient lifting sling 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Zenitec Holdings Ltd 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
    20957
  • 사례 시작날짜
    2017-01-18
  • 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: Zenitec Holdings Ltd, 135-137 Ettrick St, Invercargill 9840
  • 원인
    There have been four recorded cases of failure of the keyhole clip that attaches a sling to a pivot framed hoist. these keyhole clips are the black plastic component this is attached to the sling by means of a webbing strap threaded through a slot. the affected clips have all broken at the slot., the fault has been tracked to two batches of product which were made with incorrect machine settings by the clip manufacturer.
  • 조치
    Product to be exchanged

Device

Nortec patient lifting sling
  • 모델명 / 제조번호(시리얼번호)
    Model: , Affected: Keyhole clip
  • Manufacturer
    Zenitec Holdings Ltd

Manufacturer

Zenitec Holdings Ltd