Device Recall Aspire HD

  • Model / Serial
    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
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution and Internationally to Mexico.
  • Product Description
    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

Manufacturer

  • Manufacturer Address
    Fujifilm Medical Systems U.S.A., Inc., 419 West Ave, Stamford CT 06902-6343
  • Manufacturer Parent Company (2017)
  • Source
    USFDA