Device Recall FUJIFILM FDR Visionary Suite with CH200 stationary xray system

  • 모델명 / 제조번호(시리얼번호)
    UDI: (01)04540217052226(21)MP95A9F6B001; (01)04540217052226(21)MP95A9F6A001; (01)04540217052226(21)MP95A8F5A001.  Serial Numbers: FDR Visionary Suite System S/N MP95A9F6B001 MP95A9F6A001 MP95A8F5A001
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution.
  • 제품 설명
    FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary Suite (FMSU Marketing Name) || The FDR Visionary Suite is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations.
  • 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