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U.S. Department of Health and Human Services

Class 2 Device Recall OARM(R)

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 Class 2 Recall
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Date Posted February 04, 2009
Recall Status1 Open
Recall Number Z-0624-2009
Recall Event ID 45967
Product Classification System, X-Ray, Mobile - 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, Colorado 80027-9710
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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.