Device Recall Xltek Protektor Stimulator (EPWorks software)

  • Modèle / numéro de série
    EPWorks Software Versions prior to 6.0
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    EPWorks software used in the Xltek Protektor Stimulator || Product Usage: || Intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Natus Medical Incorporated, 2568 Bristol Circle, Oakville Canada Ontario
  • Société-mère du fabricant (2017)
  • Source
    USFDA