Arjo Lifters - Patient Transfer - Sara 3000, Sara Plus, Maxi Twin, Maxi Compact, Maxi Move, Maxi 500, Maxi Sky 440, Maxi Sky 600, Maxi Sky 1000. 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 ArjoHuntleigh AB 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
    20497
  • 사례 시작날짜
    2016-08-15
  • 사례 국가
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
  • 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: Arjo New Zealand Limited, 34 Vestey Drive, Mt Wellington, AUCKLAND 1060
  • 원인
    Internal testing and investigative activities have confirmed that the the conductive ink which is necessary for the activation of the handset function did not meet predetermined durability requirements., manufacturer to perform a replacement of handset for the maxi move floor lifts affected by this issue.
  • 조치
    Product to be exchanged

Device

  • 모델명 / 제조번호(시리얼번호)
    Model: Maxi Move Units, Affected: 300043863 to 300100386
  • Manufacturer

Manufacturer