Company: Medtronic Navigation, Inc
Date of Enforcement Report:12/5/2007
Class:ll
PRODUCT
Medtronic 0-arm Imaging System, Product Catalog Number: B1-700-00027, (software version 3.0), Recall # Z-0294-2008
REASON
Reversed Instrument Position: a defect in the software version 3.0 causes an error in the position of surgical instruments and relative motion are reversed 180′ on the StealthStation image. (If the StealthStation is not used, or if the patient orientation is prone or supine, the problem does not occur)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Navigation, Inc., Louisville, CO, by letter on October 17, 2007.
Manufacturer : Medtronic Navigation, Inc., Littleton, MA.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
Nationwide and Internationally
