Company:Medtronic Navigation, Inc
Date of Enforcement Report 2/11/2009
Class:ll

PRODUCT
Medtronic O-Arm Intraoperative Imaging System, Catalog number: Bl-700-0027, Recall # Z-0624-2009

REASON
Navigation accuracy problem: Accuracy may fall outside of specification when used in combination with the Medtronic Synergy Experience StealthStation System Spine Software with the O-Arm Intraoperative Imaging System and tracker.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Navigation, Inc., Louisville, CO, by site visits on November 27, 2007.
Manufacturer: Medtronic Navigation, Inc., Littleton, MA. Firm initiated recall is complete.

VOLUME OF PRODUCT IN COMMERCE
54 units

DISTRIBUTION
Nationwide, Canada, Czech Republic, Denmark, Germany, Netherlands, South Korea, Poland, South Africa, and Singapore