Events

CS 8100 & CS 8100 3D (A diagnostic dental 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-2015-RN-00073-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-01-29
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00073-1
  • 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 the column of a cs 8100 demonstration device descended unexpectedly as one of the two retaining clips (circlips) that holds the locating pin in place was missing. if a circlip is not placed on both ends of the locating pin, it is possible that movement and transport of a unit can cause the pin to move out of position, or fall out completely. testing showed the device operation could appear normal for several lifting cycles after the pin fell out completely due to friction holding the ends of two units together, but the jack would eventually slip off the base plate stand. no other reports, complaints or injuries of this type (related to missing circlip) have been received since the device was introduced into commercial distribution in 2012.
  • 조치
    Carestream Health Australia is organising a service call and a service engineer will attend the user’s site, make a detailed inspection and replace the column assembly if required. This action has been closed-out on 24/05/2016.

Device

CS 8100 & CS 8100 3D (A diagnostic dental x-ray system)
  • 모델명 / 제조번호(시리얼번호)
    CS 8100 & CS 8100 3D (A diagnostic dental x-ray system)Serial numbers starting WEYA618-627, WF, WG, WH, WI, WJ, WK, WL, XA, XB, XC, XD, XE, XF, XG, XH, XI, XJ, XK, XL, YA, YB, YC, YD.Manufacturing Date: June 2012 to September 2014ARTG Number: 136114 and 136106
  • 의료기기 분류등급
    Radiology Devices
  • Manufacturer
    Carestream Health Australia Pty Ltd

Manufacturer

Carestream Health Australia Pty Ltd