Device Recall Hologic MIV Mammography System

  • Model / Serial
    Serial Numbers: 1800314 7263, 180031472, 18002023051PR
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in Puerto Rico, and the states of CA, NY, and TX, and the country of Republic of Korea.
  • Product Description
    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
  • 1 Event

Manufacturer

  • Manufacturer Address
    Hologic, Inc., 36 Apple Ridge Rd # 37, Danbury CT 06810-7301
  • Manufacturer Parent Company (2017)
  • Source
    USFDA