Events

Kodak 2100 & 2200 Intraoral X-ray System (dental x-ray) 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-00142-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-02-10
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00142-1
  • 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 advice that there were five incidents overseas where an early failure of the device occurred where pivot/bracket of the arm broke allowing the arm to drop to 90°.The failure is not immediate and would be noted by the user as part of the routine maintenance inspection, before the arm can fall. should the arm fall, there is a risk of injury by impact to the patient or user.
  • 조치
    To address this issue, a service engineer will attend the customer site, make a detailed inspection and install a bracket modification/replacement kit to address the problem. In the interim, customers are recommended to undertake regular inspections of their units to ensure that the arm has not failed. This action has been closed-out on 01/02/2016.

Device

Kodak 2100 & 2200 Intraoral X-ray System (dental x-ray)
  • 모델명 / 제조번호(시리얼번호)
    Kodak 2100 & 2200 Intraoral X-ray System (dental x-ray)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.ARTG inclusion number: 136106
  • Manufacturer
    Carestream Health Australia Pty Ltd

Manufacturer

Carestream Health Australia Pty Ltd