Device Recall Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit),

  • 모델명 / 제조번호(시리얼번호)
    ISA CO2 Sensor serial numbers:  107349, 107357, 107358, 107363, 107370, 107377, 107390, 107407, 107435,  107476, 107509, 107510, 107556, 107659, 107700, 107707, 107768, 107776,  107831, 107832, 107836, 107839, and 107841.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution was made to medical facilities located in AL, FL, ID, LA, MO, NC, OK, SC, TX, and UT. There was government distribution and no foreign/military distribution.
  • 제품 설명
    Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge Part Number HW-HEMO-00001. The PhaseIn Unit is an optional accessory (sold separately) to the Merge Hemo Patient Data Module (PDM). The PDM is a major component of the Merge Hemo system.
  • Manufacturer
  • 1 Event

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