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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic 0arm Imaging System

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  Class 2 Device Recall Medtronic 0arm Imaging System see related information
Date Initiated by Firm October 17, 2007
Date Posted November 27, 2007
Recall Status1 Terminated 3 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) 
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 2		 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 and Original Applicant = BREAKAWAY IMAGING, LLC
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