Devices

Device Recall Hologic MIV Mammography System

  • Modèle / numéro de série
    Serial Numbers: 1800314 7263, 180031472, 18002023051PR
  • 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 M-IV Mammography System; Model M4--00001. || Intended to produce radiographic images of the breast. For screening and diagnostic imaging of the breast.
  • 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