Sorg Jump Alpha, Jump Beta and Vector WheelchairsWheelchairs with back tubes made of section tubes with groove Manufactured between 01/2008 - 09/2015 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Motum 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-2018-RN-00070-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-02-23
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    Motum has been made aware by the manufacturer, sorg, through continuous market observation, a potential weakness with a certain configuration of back tubes on sorg wheelchairs from the production date range of 01/2008 to 09/2015 which may result in breakage of the back tube under extreme loads. to date, there have been no injuries or harm reported as a result of this issue.
  • 조치
    Motum will be in contact with affected users to arrange for replacement of the backrest tubes.

Device

  • 모델명 / 제조번호(시리얼번호)
    Sorg Jump Alpha, Jump Beta and Vector WheelchairsWheelchairs with back tubes made of section tubes with grooveManufactured between 01/2008 - 09/2015ARTG Number: 226472(Motum - Wheelchair, attendant/occupant driven)
  • Manufacturer

Manufacturer