Devices

Device Recall Stereotaxic Navigation System

Model / Serial
Catalog Numbers: 960-201 and 9730888. Cranial Application software v.4.5.
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
Distribution
Domestic distribution: FL, CO, AZ, TX, AR, MT, OK, IL, PA, NY, LA, WI, NC, ND, CA, GA, AL, OR, WY, WA, OH, NV. Foreign distribution: Belgium, Czech Republic, China (Malaysia). No military or VA facilites.
Product Description
Stealth Station Cranial Application v.4.5
Manufacturer
Medtronic Surgical Navigation Technologies, Inc
1 Event
- Recall of Device Recall Stereotaxic Navigation System

Manufacturer

Medtronic Surgical Navigation Technologies, Inc

Manufacturer Address
Medtronic Surgical Navigation Technologies, Inc, 826 Coal Creek Cir, 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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