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/ 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 |
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
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