Class 2 Device Recall Medtronic Navigation OArm Imaging System

• Date Initiated by Firm: October 15, 2010
• Date Posted: November 23, 2010
• Recall Status: Terminated on June 04, 2012
• Recall Number: Z-0447-2011
• Recall Event ID: 57048
• 510(K)Number: K092564
• Product Classification: system, x-ray, mobile - Product Code IZL
• Product: Medtronic Navigation O-Arm Imaging System, Door Assembly (BI-700-00006) used in Product Catalog Numbers: 9732719,9733346,81-700-00027, 81-700-00027R, 81700- 00027-100, 81-700-00027-1 OOR, 81-700-00027-120, 81-700-00027-120R, 81700-00027-230, 81-700-00027-230R, 81-700-00027GER, 81-700-00027GERR Intended use: Designed for 2D fluoroscopic and 3D imaging and is intended to be used by a physician benefits from 2D and 3D information of anatomic structures with high x-ray attenuation such as bony and metallic objects.
• Code Information: All Units distributed from June 2006 through September 2010
• Recalling Firm/ Manufacturer: Medtronic Navigation, Inc.; 300 Foster St; Littleton MA 01460-2017
• For Additional Information Contact: SAME; 978-339-6426
• Manufacturer Reason for Recall: Safety Notice: Door Cable Periodic Maintenance Schedule and Cable Wear for the O-ARM Imaging System Breakage of the door cable during opening and closing may occur and cause physical harm or delay of therapy
• FDA Determined Cause: Equipment maintenance
• Action: Medtronic Navigation sent all consignees/customers an "Urgent Field Safety Notice" letter dated October 15, 2010. The letter described the product, problem and action to be taken by the customers. The customers were instructed to review and follow the attached information that describes the process to properly detect and proactively manage cable wear; to ensure that the door is completely open when positioning the patient into or removing them from the gantry and when placing the O-ARM Imaging System Tube Drape (BI-900-00003) onto the unit, and report any visual or audible (cracking noise) wear of the cable to Medtronic Representative ASAP. Note: A Medtronic Representative will be contacting the customers within the coming weeks to schedule a time to inspect the current condition of the cable, explain and train the customers on the recommended workflow and inspection procedure and place a permanent label on their O-ARM Imaging System to reinforce these actions. If you have any questions about this notification, please contact your local Medtronic Navigation representative or call our Technical Services Group at 800-595-9709 or 720-890-3200.
• Quantity in Commerce: 244 units
• Distribution: Worldwide distribution: USA including states of: AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, and WI; and countries including: Canada, Austria, Australia, Belgium, Brazil, Libya, South Africa, India, Japan, Singapore South Korea, Haiti, Kuwait, Saudi Arabia, Turkey, UAE, Germany, Netherlands, Great Britain, Italy, Poland, Netherlands, Spain,Sweden, and Switzerland.
• Total Product Life Cycle: TPLC Device Report

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 = IZL