Device Recall Monica Novii Wireless Patch System

  • 모델명 / 제조번호(시리얼번호)
    Model # - 107-PT-020 ( all units distributed from January 2016- November 2017)
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide - US Nationwide Distribution.
  • 제품 설명
    Uterine Electromyographic Monitor - Monica Novii Wireless Patch System || Product Usage: || The Novii Interface is an accessory to the Novii Pod which provides a means of interfacing the wireless output of the Novii Pod to the transducer inputs of a CTG Fetal monitor via three cables. The Novii Interface enables signals collected by the Novii Pod to be printed and displayed on a CTG Fetal Monitor and sent on to a central network, if connected.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • 제조사 모회사 (2017)
  • Source
    USFDA