Device Recall Fujifilm Medical Systems

  • 모델명 / 제조번호(시리얼번호)
    Software Versions: Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including PR and the states of IL, IN, FL, GA, MD, MI, MO, MS, NC, NY, OR, and PA, PR and the country of Canada.
  • 제품 설명
    Fujifilm Synapse Cardiovascular I ProSolv CardioVascular || Synapse Cardiovascular v4.0.8 || Synapse Cardiovascular v4.0.8 SR1 || Intended Use: || Picture Archiving and Communication System || Computer, Diagnostic, Programmable
  • 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