Events

Non CE-marked portable dental X-ray units 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Zhengzhou Tianjie Electronic Equipment Co 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert / Field Safety Notice
  • 사례 ID
    MDA/2012/046
  • 사례 연번
    CON173752
  • 날짜
    2012-07-16
  • 사례 출판 날짜
    2012-07-16
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON173752?tabName=allTabs
  • 비고 / 경고
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • 데이터 추가 비고
  • 원인
    Testing by the health protection agency (hpa) has revealed that the tianjie dental falcon device lacks sufficient shielding in the x-ray tube, which could give rise to high patient doses and under typical high radiographic workloads result in operator doses in excess of the ionising radiation regulations 1999 annual dose limits. this could give rise to adverse health effects caused by radiation. the tianjie dental falcon is not ce-marked as a medical device.
  • 조치
    Identify and stop using this and similar non CE-marked devices. Replace the device with a suitable CE-marked alternative. Be aware of the NRPB (HPA) Guidance Notes for Dental Practitioners on the Safe Use of X-Ray Equipment or the Medical & Dental Guidance Notes published by IPEM. Be aware of the general requirement to consult a suitable radiation protection adviser with regard to the use of X-ray equipment. Be aware of MHRA advice on the use of non-CE marked devices. Report any suspected devices to MHRA Adverse Incident Centre.

Device

Non CE-marked portable dental X-ray units
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Non CE-marked portable dental X-ray units. Including the Tianjie Dental ‘Falcon’. The Tianjie Dental Falcon portable X-ray unit is not CE-marked as a medical device and was purchased on eBay. It is identical in appearance to a number of other non CE-marked devices that are available on the internet:
  • Manufacturer
    Zhengzhou Tianjie Electronic Equipment Co

Manufacturer

Zhengzhou Tianjie Electronic Equipment Co
  • Source
    MHRA