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
  • 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
  • 1 Event

제조사

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