Class 2 Device Recall Medtronic 0arm Imaging System

• Date Initiated by Firm: October 17, 2007
• Date Posted: November 27, 2007
• Recall Status: Terminated on November 27, 2007
• Recall Number: Z-0294-2008
• Recall Event ID: 45492
• 510(K)Number: K050996
• Product Classification: Imaging System - Product Code JZL
• Product: Medtronic 0-arm Imaging System, Product Catalog Number: B1-700-00027, Medtronic Navigation, Inc., Littleton, MA 01460 (software version 3.0)
• Code Information: System Serial Numbers: 103, 104, 109, 117, 119 (Germany) 125, and 144 (Canada)
• FEI Number: 1000517638
• Recalling Firm/ Manufacturer: Medtronic Navigation, Inc; 826 Coal Creek Circle; Louisville CO 80027-9710
• For Additional Information Contact: 720-890-3200 Ext. 3303
• Manufacturer Reason for Recall: 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)
• FDA Determined Cause: Software change control
• Action: Medtronic Navigation notified customers by letter on October 17, 2007. Medtronic Field service will perform upgrade (software version 3.0.1) at user site.
• Quantity in Commerce: 7 units
• Distribution: Worldwide: USA including states of CO, IN, NE, and MN and countries of Canada and Germany

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JZL