Events

Oxford Advance only manufactured prior to July, 2010 (Prior to serial number 1007L0001) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Sunrise Medical 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-2014-RN-00012-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-01-08
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00012-1
  • 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
    Two reported incidences have occurred since the product was first released in december 2004, where the upper base casting has fractured. the looseness or removal of the four screws that locate the base plate to the upper base casting may allow the base casting to be distorted or weakened under load and possibly fracture if excessive force is applied.This recall action undertaken in february 2013 was carried out prior to the approval of the recall strategy by the tga.
  • 조치
    Sunrise Medical is advising users that affected units will be upgraded as part of the next scheduled inspection. This action has bee closed-out on 12/02/2016.

Device

Oxford Advance only manufactured prior to July, 2010 (Prior to serial number 1007L0001)
  • 모델명 / 제조번호(시리얼번호)
    Oxford Advance only manufactured prior to July, 2010 (Prior to serial number 1007L0001)ARTG Number: 101303
  • Manufacturer
    Sunrise Medical Pty Ltd

Manufacturer

Sunrise Medical Pty Ltd