Devices

Device Recall Surgical Navigation System

Model / Serial
Serial Numbers: P703048, P703049, P703050, P703054, P703055, P703060, P703061, P703063, P703066, P703068, P703070, P703076, P703077, P703079, P703114, P703140, P703141, P703143.
Product Classification
Neurological Devices
Device Class
2
Implanted device?
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.
Product Description
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
Medtronic Navigation, Inc
1 Event
- Recall of Device Recall Surgical Navigation System

Manufacturer

Medtronic Navigation, Inc

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

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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