Drystar DT 2 C Hardcopy Film 14" x 17" 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-2017-RN-01371-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-10-30
  • 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
    Agfa healthcare is advising that due to an error in manufacturing, specific film boxes have unreadable rf-tags. if these boxes are used in printers, the printer will generate an error message, and it will not be possible to print images. if users were able to use the affected film there is no problem with the image quality or the diagnostic properties.
  • 조치
    Agfa Healthcare is advising users to use an alternative film if the issue occurs.

Device

  • 모델명 / 제조번호(시리얼번호)
    Drystar DT 2 C Hardcopy Film 14" x 17"Reference: EKMCUBatch Numbers: 36650011 (exp 2018-06) and 69030031 (exp 2018-10)ARTG Number: 119352 (AGFA HealthCare Australia - Photographic film, diagnostic imaging)
  • Manufacturer

Manufacturer