Devices

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

  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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
    Merge Healthcare, Inc.
  • 1 Event

Fabricant

Merge Healthcare, Inc.