DX-D 100 Digital Radiography X-Ray SystemAll Units 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 AGFA HealthCare Australia 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-00674-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-06-25
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    When liquid comes in contact with the dx-d 100 touch screen, the device may incorrectly recognise this as user input altering device settings. capacitive touch screens rely on the electrical properties of the human body to enable users to operate the device with very light touches of a finger. however, when liquid comes in contact with the touch screen it may incorrectly recognise this as user input. for example, it could unexpectedly change the exposure settings.
  • 조치
    Users are advised that they must ensure their hands are dry before using the touch screen of the DX-D 100 because liquid residue may activate the action buttons on the touch screen. The following advice is provided in the customer letter in addition to referring users to the warning in the user manual:: - Do not operate touch screen monitor with wet hands. - Do not let liquids come in contact with the touch screen while the DXD 100 is powered on. - Always double check your parameter settings prior to exposing the patient.

Device

  • 모델명 / 제조번호(시리얼번호)
    DX-D 100 Digital Radiography X-Ray SystemAll UnitsARTG Number: 178856
  • Manufacturer

Manufacturer