Device Recall AliveECG App Version 2.1.2 used with AliveCor Heart Monitor

  • Modèle / numéro de série
    v2.1.2
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Downloaded by Apple users - locations not shared by Apple.
  • Description du dispositif
    Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operating system, intended to be used with the AliveCor Heart Monitor. The AliveCor Heart Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The AliveCor Heart Monitor also displays ECG rhythms and detects the presence of atrial fibrillation and normal sinus rhythm (when prescribed or used under the care of a physician).
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Alivecor SFO, 30 Maiden Ln, Suite 600, San Francisco CA 94108-5429
  • Société-mère du fabricant (2017)
  • Source
    USFDA