Device Recall Aspire HD

  • 모델명 / 제조번호(시리얼번호)
    FDR MS-2500 made in Japan : S/N- 16640001 or later  FDR MS-2500 made in China : S/N- 26860001 or later  FDR MS-2000 made in Japan : S/N- 16650001 or later  FDR MS-2000 made in China : S/N- 26870001 or later
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution and Internationally to Mexico.
  • 제품 설명
    Aspire HD Plus (FDR MS-2500), also known as Aspire HD Plus F and Aspire HD-s (FDR MS-2000), || also known as Aspire HD Plus S). Mammography machine || The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field digital mammography images that can, as other fall-field digital mammography systems, be used for screening and diagnosis of breast cancer and are intended for use in the same clinical applications as traditional screen-film mammography systems.
  • 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