MAXIMOVE PATIENT LIFT 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 ARJO CANADA INC. 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
    123218
  • 사례 위험등급
    III
  • 사례 시작날짜
    2017-11-03
  • 사례 국가
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • 데이터 추가 비고
  • 원인
    Arjohuntleigh has been made aware from internal testing and investigative activities that the conductive ink which is necessary for the activation of the handset function did not meet predetermined durability requirements. as part of our efforts to ensure customer satisfaction and product quality and performance arjohuntleigh has decided to perform a replacement of handset for the maxi move floor lifts affected by this issue which is not expected to affect the safety of the device but rather its durability.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: KMC*** (Lot serial: >100 numbers contact mfg)
  • 제품 설명
    ARJOHUNTLEIGH MAXI MOVE HANDSET
  • Manufacturer

Manufacturer

  • 제조사 주소
    MISSISSAUGA
  • 제조사 모회사 (2017)
  • Source
    HC