Device Recall Rheo Knee

  • Modèle / numéro de série
    Rheo 2 Item Number: RKN120007  Serial #s affected:  323056 321498
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: US distribution in TN and country of: Austria.
  • Description du dispositif
    The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations. RHEO KNEE uses Artificial Intelligence to continuously adapt to the users walking style and environment. The RHEO KNEE recognizes and responds immediately to changes in speed, load and terrain, restoring the users ability to walk naturally, comfortably and confidently at any speed.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Ossur H / F, Grjothals 5, Reykjavik Iceland
  • Société-mère du fabricant (2017)
  • Source
    USFDA