Devices

Device Recall Drystar AXYS

  • Modèle / numéro de série
    ID number EYZ4E, Serial numbers: 1024 to 1189; but excluding 1053, 1057, 1089, 1096, 1097, 1098, 1101, 1103, 1161, 1166, 1173, 1176, 1177, 1178, 1180, 1181, 1185, 1186, 1187 and 1188.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution --- USA including states of DE, FL, IL, KS, MA, MD, ME, MO, MT, NJ, NY, OH, OK, TX, UT, VA, WA, WV, and Puerto Rico and country of Canada.
  • Description du dispositif
    Drystar AXYS, Hardcopy Printer || A free standing device used to print diagnostic conventional and mammography images on transparent film for viewing on a standard view box. It may be used in any situation in which a hard copy of an image generated by a medical imaging device is required or desirable.
  • Manufacturer
    AGFA Corp.
  • 1 Event

Fabricant

AGFA Corp.
  • Adresse du fabricant
    AGFA Corp., 10 S Academy St, Greenville SC 29601-2632
  • Source
    USFDA