Events

Carina Mobile LiftsAll Models and Series 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Active Medical Supplies Pty 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
    RC-2017-RN-00516-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-05-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00516-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    The manufacturer, handicare, has identified the possibility that the carina mobile lift could be mounted incorrectly by users in two respects. namely, the lift arm and actuator could be incorrectly mounted and/or the mast with lift arm could be incorrectly mounted.If the connection between lift arm and actuator is incorrectly mounted, there is a possibility that a metal part on top of the actuator (i.E. piston rod eye flange) fractures when subjected to certain weight loads. in the event that the mast is not fully inserted into the mast base and standing upright in a vertical position, there is a possibility that the mast falls forward when subjected to weight load. therefore, there is a risk that an incorrectly mounted mobile lift would cause injury upon use.
  • 조치
    Active Medical Supplies is requesting users to follow the additional instructions regarding the inspection of the connection between the lift arm and actuator as well as the positioning of the mast to prevent incorrect mounting of the mobile lifts. The instructions are contained in Annexes A and B (respectively) of the recall notification and are intended to supplement the Instructions for Use (IFU). Users are advised that the updated IFU is available for download from the manufacturer's website.

Device

Carina Mobile LiftsAll Models and Series

Manufacturer

Active Medical Supplies Pty Ltd