Device Recall Viterion V100 Telehealth Monitors

  • Modèle / numéro de série
    All units are affected. List of affected serial numbers were provided as Excel spreadsheet due to the large volume.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the United Kingdom.
  • Description du dispositif
    Viterion TeleHealth Monitor Model Number V100, Product Codes 09377512 (US) and 04480218 (UK). Physiological patient monitor (without arrhythmia detection or alarms). Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Viterion TeleHealthcare Llc, 555 White Plains Rd, Tarrytown NY 10591-5101
  • Société-mère du fabricant (2017)
  • Source
    USFDA