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U.S. Department of Health and Human Services

Class 2 Device Recall OARM(R)

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  Class 2 Device Recall OARM(R) see related information
Date Initiated by Firm November 27, 2007
Date Posted February 04, 2009
Recall Status1 Terminated 3 on January 22, 2016
Recall Number Z-0624-2009
Recall Event ID 45967
510(K)Number K050996  K060344)  
Product Classification Mobile X-Ray System - Product Code IZL
Product Medtronic O-Arm Intraoperative Imaging System
Catalog Number: BI-700-00027
Code Information Software versions prior to version 3.0.2 S/N: 102-155
Recalling Firm/
Medtronic Navigation, Inc
826 Coal Creek Circle
Louisville CO 80027-9710
For Additional Information Contact
720-890-3200 Ext. 3303
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Software design
Action Medtronic Navigation notified Field representatives on 11/27/07 to perform site visits to implement FCA 2007-005 - O-Arm Intraoperative Imaging System Accuracy, and deliver the Customer Letter notification. Confirmation of the visit was documented.
Quantity in Commerce 54 units
Distribution Worldwide Distribution: USA, Canada, Czech Republic, Denmark, Germany, Netherlands, S. Korea, Poland, South Africa, and Singapore
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 and Original Applicant = BREAKAWAY IMAGING, LLC