Device Recall Aspire HD

  • Modèle / numéro de série
    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
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution and Internationally to Mexico.
  • Description du dispositif
    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

Fabricant

  • Adresse du fabricant
    Fujifilm Medical Systems U.S.A., Inc., 419 West Ave, Stamford CT 06902-6343
  • Société-mère du fabricant (2017)
  • Source
    USFDA