Events

Device Recall FUJIFILM Synapse Workstation Versions 4.4.000, 4.4.001, 4.4.004, 4.4.010, and 4.4.020 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
    74372
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2043-2016
  • 사례 시작날짜
    2016-05-10
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147292
  • 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
    System, image processing, radiological - Product Code LLZ
  • 원인
    Synapse cannot display image files, dicom sr files, and/or annotation files. the "image not loaded" message displays instead.
  • 조치
    The firm, FujiFilm, sent an "MEDICAL DEVICE CORRECTION" letter dated May 10, 2016 via Federal Express to its customers. The letter describes the product, problem and actions to be taken.The customers were instructed to: Extend the Ad hoc deletion retention period or discontinue use of Ad Hoc Deletion, and complete and submit the attached Customer Response Form to Fujifilm via fax to (203)-251-7863. Affected systems will be corrected via on-site visits by FMSU Customer Service Engineers upgrading to Version 4.4.100. Questions or concerns, contact the FUJI FILM Customer Support Center at 1- 888-FUJIMED Option #1 .

Device

Device Recall FUJIFILM Synapse Workstation Versions 4.4.000, 4.4.001, 4.4.004, 4.4.010, and 4.4.020
  • 모델명 / 제조번호(시리얼번호)
    Software version: 4.4.000, 4.4.001, 4.4.004, 4.4.010, 4.4.020
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution to states of: CA, FL, KS, NE, NY, and PA.
  • 제품 설명
    Fujifilm Synapse PACS software version 4.4.000, || Fujifilm Synapse PACS software version 4.4.001, || Fujifilm Synapse PACS software version 4.4.004, || Fujifilm Synapse PACS software version 4.4.010 and || Fujifilm Synapse PACS software version 4.4.020 || FUJIFILM Synapse Workstation Software (a Picture Archiving And Communications System) is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. Also intended for installation on an || off-the-shelf PC networked with Fuji Synapse PACS.
  • 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