Device Recall Monica IF24 Interface System

  • Model / Serial
    Model # - 105-PT-001 ( all units distributed from October 2011 - May 2016)
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide - US Nationwide Distribution.
  • Product Description
    Uterine Electromyographic Monitor -Monica IF24 Interface System || Product Usage: || The Monica IF24 CTG Interface Device is an accessory to the Monica AN24 which provides a means of interfacing the wireless output of the Monica AN24 to the transducer inputs of a CTG Fetal monitor. The Monica IF24 CTG Interface Device enables signals collected by the Monica AN24 to be printed and displayed on a CTG Fetal Monitor and sent on to a central network, if connected. The device is intended for use by healthcare professionals in a clinical setting.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
  • Source
    USFDA