Devices

Device Recall Horizon Cardiology Hemo Monitoring System

  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers of subassemblies (ECUs) that contain the affected power supply: A0199, A0200, A0201, A0205, A0208, A0209, A0210, A0225, A0232, A0233, A0234, A0235, and A0236
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide to hospital and medical centers in LA. CA, PA and IL,
  • 제품 설명
    Horizon Cardiology Hemo Monitoring System;Horizon Cardiology Hemo External Control Unit;~100 - 230 VAC || 50-50 Hz, Medcon Telemedicine Technology LTD.,Tel Aviv, 697190, Israel.
  • Manufacturer
    McKesson Provider Technologies
  • 1 Event

제조사

McKesson Provider Technologies
  • 제조사 주소
    McKesson Provider Technologies, 628 State Route 10, Whippany NJ 07981-1522
  • Source
    USFDA

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Device Recall Horizon Cardiology Hemo Monitoring System
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers: 2008052847, 2008072107, 2008092609, 2008092608, 2009010800, 2008121714, 2008101609, 2008101608, 2008101618, 2008110391, 2008110390, 2008110389, 2009020226, 2009020227, 2009030603, 2009030602, 2009030601, 2009110399, 2008110398, 2008051520, 2008051519, 2008051518.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution: CA, CT, FL, LA, NC, TN, WA, and WV.
  • 제품 설명
    Horizon Cardiology Hemo Monitoring System || A programmable diagnostic computer intended for acquiring digitizing, storing, displaying , and reviewing hemodynamic data for use in hospital cardiac catherization laboratories.
  • Manufacturer
    McKesson Provider Technologies - Medical Imaging Group