Events

Device Recall FUJIFILM Digital Mammography System Aspire HD (FDR MS1000) with Biopsy Positioner (FDR1000BPY) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Fujifilm Medical Systems U.S.A., Inc. 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
    74525
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2690-2016
  • 사례 시작날짜
    2016-06-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-09-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147840
  • 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
    Full field digital,system,x-ray,mammographic - Product Code MUE
  • 원인
    If an exposure is aborted during a stereo biopsy workflow, an error may occur which would prevent the system from continuing to operate properly.
  • 조치
    The firm, Fujifilm, sent a "FIELD SAFETY NOTICE" letter dated June 9, 2016 via Federal Express to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to read and follow the instructions in the letter; call your local service representative, in case an error occurs, and complete and return the Customer Feedback Form via fax (203)-251-7862. Both affected systems will be corrected via on-site visits by FMSU Customer Service Engineers. If you have any questions about this matter, please contact the Product Manager, Women's Health directly at (303)-888-4549 or call your local FUJIFILM office.

Device

Device Recall FUJIFILM Digital Mammography System Aspire HD (FDR MS1000) with Biopsy Positioner ...
  • 모델명 / 제조번호(시리얼번호)
    26330437 and 17230408
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution to: NC and HI.
  • 제품 설명
    FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner (FDR-1000BPY) || The Fujifilm Digital Mammography System, Aspire HD (FDR MS-1000), generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems.
  • Manufacturer
    Fujifilm Medical Systems U.S.A., Inc.

Manufacturer

Fujifilm Medical Systems U.S.A., Inc.
  • 제조사 주소
    Fujifilm Medical Systems U.S.A., Inc., 419 West Ave, Stamford CT 06902-6343
  • 제조사 모회사 (2017)
    FUJIFILM Holdings Corp.
  • Source
    USFDA