—#65617

Product

Medtronic 0-arm Imaging System, Product Catalog Number: B1-700-00027, Medtronic Navigation, Inc., Littleton, MA 01460 (software version 3.0)

FDA product code: JZL
510(k) numbers: K050996
Affected lot / code info: System Serial Numbers: 103, 104, 109, 117, 119 (Germany) 125, and 144 (Canada)

Why it was recalled

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)

Root cause (FDA determination)

Software change control

Action the firm took

Medtronic Navigation notified customers by letter on October 17, 2007. Medtronic Field service will perform upgrade (software version 3.0.1) at user site.

Recalling firm

Firm: Medtronic Navigation, Inc
Address: 826 Coal Creek Circle, Louisville, Colorado 80027-9710

Distribution

Distribution pattern: Worldwide: USA including states of CO, IN, NE, and MN and countries of Canada and Germany

Timeline

Recall initiated: 2007-10-17
Posted by FDA: 2007-11-27
Terminated: 2007-11-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #65617. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.