Device Recall Surgical Navigation System

  • Modèle / numéro de série
    Serial Numbers: P703048, P703049, P703050, P703054, P703055, P703060, P703061, P703063, P703066, P703068, P703070, P703076, P703077, P703079, P703114, P703140, P703141, P703143.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA including states of: CA, CO, GA, SC, TN, and WI; and countries including: Australia, Canada, Chile, Russia, Saudi Arabia, and South Africa.
  • Description du dispositif
    Polaris Spectra Position Sensor Unit, a component of the StealthStation S7 System, Medtronic Navigation, Louisville, CO 80027. || The Polaris Spectra Position Sensor Unit (PSU) is the component of the StealthStation S7 System which detects optical markers on instruments and reference frames, determines their spatial positions, and continuously reports this information to the system computer. The computer uses this spatial information, in conjunction with information regarding the geometry of the instrument currently in use, to determine where the tip of the instrument is located on the patient anatomy.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Medtronic Navigation, Inc, 826 Coal Creek Circle, Louisville CO 80027-9710
  • Source
    USFDA