Events

DRX Revolution Mobile X-Ray System 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Carestream Health 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-2014-RN-01267-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-12-04
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01267-1
  • 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
    Carestream health australia pty ltd has received a report that an overseas service engineer observed a loose boom arm during routine maintenance on a drx revolution mobile x-ray system as one of three bolts that secure the boom to the carriage had fractured and the other two bolts were loose causing the boom arm to become loose. no other reports of this type have been received since the device was introduced into commercial distribution in 2009.It was determined from the engineering assessment that the bolts installed in this specific carriage were not tightened to the required torque spec which could cause bolt failure due to bending fatigue.
  • 조치
    Carestream Health Australia is arranging for a service visit to affected customers to identify loose booms and replace carriage attachment bolts. This action has been closed-out on 07/06/2016.

Device

DRX Revolution Mobile X-Ray System

Manufacturer

Carestream Health Australia Pty Ltd