Events

T2100 Treadmill 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 GE Healthcare Australia 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-2015-RN-00259-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-03-19
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00259-1
  • 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
    A performance issue with the t2100 treadmills can cause uncontrolled walking belt motion during a stress exercise test. this motion can be seen as an unexpected slowing, followed by sudden belt acceleration in either the forward or backward direction. when this occurs, engaging the emergency stop button (estop) will not immediately stop the belt. rather, it will coast to a stop within 35 seconds when slowing from maximum speed. the sudden change in belt speed and/or direction can result in a fall and injury to the patient.
  • 조치
    GE Healthcare is providing work around instructions to minimise the risk of an unexpected change in speed or direction. GE will correct all affected units onsite. This action has been closed-out on 12/08/2016.

Device

T2100 Treadmill

Manufacturer

GE Healthcare Australia Pty Ltd