Events

Mizuho OSI 5855 Orthopedic Table Top Manufactured January 1996 through December 2007 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Life Healthcare 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-2013-RN-00069-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-01-22
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00069-1
  • 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
    This action has been initiated to eliminate the risk of de-lamination of the epoxy bond between the 5855-01 orthopedic table spar's aluminium insert and the carbon fibre spar itself. if the epoxy bond fails the aluminium plug may migrate out of the carbon fibre tube.
  • 조치
    Customers are being advised to inspect the table top for any evidence of a shift of the aluminium plug from the carbon spar and immediately contact LifeHealthcare if apparent. Hospitals will be contacted to schedule an appointment to replace the table spar.

Device

Mizuho OSI 5855 Orthopedic Table Top Manufactured January 1996 through December 2007
  • 모델명 / 제조번호(시리얼번호)
    Mizuho OSI 5855 Orthopedic Table TopManufactured January 1996 through December 2007ARTG 183118
  • Manufacturer
    Life Healthcare Pty Ltd

Manufacturer

Life Healthcare Pty Ltd