Events

James Leckey Design Mygo Stander Size 2 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 James Leckey Design 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
    20361
  • 사례 시작날짜
    2016-07-14
  • 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: Allied Medical Ltd, 29 Triton Drive, North Harbour, Auckland
  • 원인
    James leckey design mygo stander is a 3-in-1 prone, supine and upright stander that supports children with severe disabilities aged 4 to 14 years while standing., it has been identified that the angle adjustment mechanism for the standersmanufactured during a specific period (jan 2012 to august 2013) allows the user to lock out the frame's safety pull pin and adjust the angle using one hand. if the operator's hand slips off the turning handle when a patient is in the frame, the handle could 'self-wind' and spin rapidly as the stander returns to the upright position., if this occurs, while there is no risk to the patient in the frame, there is a small risk that the fast spinning handle could injure the operator if they try to take hold of it., the mechanism design was changed in august 2013 and it is not possible to lock out the safety pull pin in standers manufactured since then. two hands are required to adjust the stander angle in newer models.
  • 조치
    Product to be modified

Device

James Leckey Design Mygo Stander Size 2

Manufacturer

James Leckey Design Ltd