Curix Opthos H 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 AGFA Corp. 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
    60166
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0285-2012
  • 사례 시작날짜
    2011-10-04
  • 사례 출판 날짜
    2011-11-25
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2011-12-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Film, radiographic - Product Code IWZ
  • 원인
    The film notch was located in the wrong position.
  • 조치
    An "URGENT SAFETY NOTICE" letter was sent via email to the dealers on October 7, 2011. The letter describes the problem and mitigation. Acknowledgment, via FAX-Back or email, that the information was received and understood has been requested from the dealer sites. Included in each dealer letter, Agfa also provided a customer notification letter to be sent to their end-use customers. Agfa has requested dealers and end-use customers to file a complaint at 1-877-777-2432 for any identified product still in their inventories. Agfa will replace product and arrange for return shipment.

Device

  • 모델명 / 제조번호(시리얼번호)
    79890049
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, including the states of IN, KS, MI, MN, MO, NC, NE, NY, OH, and TN and the country of Canada.
  • 제품 설명
    Curix Opthos H, size 35x43 cm || A radiographic medical x-ray film designed to optimize diagnostic chest imaging by providing complete diagnostic information including superbly visualized lung detail along with a high level of retro-cardiac, sub-diaphragmatic and mediastinal information.
  • Manufacturer

Manufacturer

  • 제조사 주소
    AGFA Corp., 10 S Academy St, Greenville SC 29601-2632
  • Source
    USFDA