Device Recall Polaris Spectra System Control Unit

Lots received from NDI (supplier) between May 1, 2020, and July 31, 2010.

Neurological Devices

2

No

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.

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.