Devices

Device Recall Polaris Spectra System Control Unit

Model / Serial
Lots received from NDI (supplier) between May 1, 2020, and July 31, 2010.
Product Classification
Neurological Devices
Device Class
2
Implanted device?
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.
Product Description
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
Medtronic Navigation, Inc
1 Event
- Recall of Device Recall Polaris Spectra System Control Unit

Manufacturer

Medtronic Navigation, Inc

Manufacturer Address
Medtronic Navigation, Inc, 826 Coal Creek Circle, Louisville CO 80027-9710
Source
USFDA

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