Device Recall Polaris Spectra System Control Unit

  • Modèle / numéro de série
    Lots received from NDI (supplier) between May 1, 2020, and July 31, 2010.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- US, including states of AL, AZ, CO, FL, GA, KY, MD, MN, NE, PA, TX, WI, and MD and countries of Australia, Belgium, Canada, Czech Republic, Italy, Netherlands, Poland, Portugal, Saudi Arabia, Singapore, South Korea, Spain, Turkey, and UAE.
  • Description du dispositif
    Polaris Spectra System Control Unit, a component of the StealthStation S7 System. Medtronic Navigation, Louisville, CO 80027. || Intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures.
  • Manufacturer
  • 1 Event

Fabricant

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