Digital Radiography X-Ray System DX-D 100 Type 5410 or DX-D 100 Wireless Type 5411 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-2015-RN-00474-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-06-02
  • 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
    1) when using the dx-d 100 unit, sporadic unintended movements may be caused by an electrostatic discharge of the unit to the ground may occur.2) capacitive touch screens rely on the electrical properties of the human body to enable you to operate the device with very light touches of a finger. however, when liquid comes in contact with the touch screen it may incorrectly recognize this as user input. this issue was notified to users previously (tga ref:. rc-2014-rn-00674-1). a software fix to mitigate this issue will be implemented as part of this action.
  • 조치
    1) A newly designed arrestor with a resistance of 1M ohm between frame and floor (ground) will be installed. Together with an update of Digital Motion Control (DMC) firmware this will prevent sporadic unintended movements. In the interim, users are advised that the unit is equipped with a safety switch in the drive handle and in case of an unintended movement, they should release the drive handle and the unit will stop. 2) A software update to change the behaviour of the touch screen so that holding the up or down button will change the value setting just a single step will limit the influence of an unintentional touch screen activation. In the interim, the operator must make sure that both hands and the touch screen are dry before utilizing the touch screen. The operator always should double check and verify the selected parameters and settings immediately before making an exposure (Ref. former letter (TGA ref:. RC-2014-RN-00674-1) and/or User Manual addendum communication). This action has been closed-out on 19/08/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    Digital Radiography X-Ray System DX-D 100 Type 5410 or DX-D 100 Wireless Type 5411ARTG Number 178856
  • Manufacturer

Manufacturer