Device Recall 8K Cardioplegia Monitor

  • 모델명 / 제조번호(시리얼번호)
    Cardioplegia Catalog Number 16414 and Serial Numbers 2060, 3305, 3763, 3823, 3834, 3835, 3851-3876, 3878-3899, 3901, 3902, 3904, 3906-3913, 3915-3933 and 3935. Also, catalog number 816373, Serial numbers 491212, 498329, 505891, 505892, 509307, 510221, 512688, 514493, 517238, 522537, 524438, 527767, 534182, 541101, 545173, 551503, 557425, 563225, 568962 and 576045.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution--USA (nationwide) including the states of AL, AR, CA, CO, GA, IL, IN, MS, NC, OH, TN, VA, and WI and countries of Belgium, Columbia, Hong Kong, India, Singapore, and Taiwan.
  • 제품 설명
    Sarns 8000 Cardioplegia Monitor, Catalog Number 16414; also known as PROG COMP BD AMPRO 420 CPG 8K, Catalog Number 816373 || The Sarns 8000 Cardioplegia Monitor is indicated to measure extracorporeal line pressure and signal when the pressure exceeds the operator-set limit.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Road, Ann Arbor MI 48103-9586
  • 제조사 모회사 (2017)
  • Source
    USFDA