Devices

Device Recall Hologic Selenia Full Field Digital Mammography System

  • Modèle / numéro de série
    Serial Numbers: 2840314W8065, 2840314W8062W, 2840314W8066W, 2840314W8067 2840314W8073, 2840314W8064, 2840314W8056W, 28401082720 28407083579, 28401137611W, 28403083045W
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed in Puerto Rico, and the states of CA, NY, and TX, and the country of Republic of Korea.
  • Description du dispositif
    Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039. || The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer.
  • Manufacturer
    Hologic, Inc.
  • 1 Event

Fabricant

Hologic, Inc.
  • Adresse du fabricant
    Hologic, Inc., 36 Apple Ridge Rd # 37, Danbury CT 06810-7301
  • Société-mère du fabricant (2017)
    Hologic Inc
  • Source
    USFDA