Events

Arjo-Huntleigh Concerto & Basic Shower Trolleys 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
    20193
  • 사례 시작날짜
    2016-05-25
  • 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: Arjo New Zealand Limited, 34 Vestey Drive, Mt Wellington, AUCKLAND 1060
  • 원인
    There have been a number of complaints where the bolts under the stretcher have become loose. there has been one minor injury as a result of a patient falling related to these incidents. manufacturer investigated the issue and the conclusion was that he stretcher mounting bolts or stretcher tilting mechanism can become loose which may make the device unstable, providing a potential for risk to the patient or the caregiver. there is a risk the locking mechanism for the stretcher-tilt function may not engage properly, resulting in a patient falling to the floor., the issue relates to a batch of devices manufactured between 7th march 2014 and 20th april 2015.
  • 조치
    Product to be modified

Device

Arjo-Huntleigh Concerto & Basic Shower Trolleys
  • 모델명 / 제조번호(시리얼번호)
    Model: , Affected: batch of devices manufactured between 7th March 2014 and 20th April 2015.
  • Manufacturer
    ArjoHuntleigh AB

Manufacturer

ArjoHuntleigh AB