Events

Handicare System RoMedic ReTurn 7400 and 7500 Patient Transfer device 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Handicare 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
    16761
  • 사례 시작날짜
    2014-07-28
  • 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: Active Rehab Equipment, 25 Rennie Drive, Airport Oaks, Auckland
  • 원인
    During the period april 2009 to may 2011, handicare ab used a wing handle in which the screw and the handle, after repeated tightening, may slide apart. this causes a small play in the attachment of the ladder, which in turn results in high load at the attachment holes of the ladder. eventually this may cause mechanical fatigue in the material of the ladder.
  • 조치
    Product to be modified

Device

Handicare System RoMedic ReTurn 7400 and 7500 Patient Transfer device
  • 모델명 / 제조번호(시리얼번호)
    Model: Models 7400 and 7500, Affected: Manufactured between Apr-2009 and May 2011
  • Manufacturer
    Handicare AB

Manufacturer

Handicare AB