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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Navigation Oarm O2 Surgical Imaging System

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  Class 2 Device Recall Medtronic Navigation Oarm O2 Surgical Imaging System see related information
Date Initiated by Firm September 22, 2016
Date Posted October 11, 2016
Recall Status1 Terminated 3 on May 12, 2017
Recall Number Z-0070-2017
Recall Event ID 75279
510(K)Number K151000  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number: BI-700-02000

Product Usage:
The O-arm Surgical Imaging System is a multi-dimensional surgical imaging platform that is designed for use in spine, orthopaedic, and trauma-related surgeries. It provides real-time, intra-operative imaging of a patients anatomy with high quality images and a large field-of-view in both two and three dimensions
Code Information Software revisions 4.0.0, 4.0.1 and 4.0.2. System Serial Numbers: C0930  C0981  C0986  C1113 C1069 C1050 C1208 C1043 C1144 C1163 C1145 C1162 C1002 C1074 
Recalling Firm/
Manufacturer		 Medtronic Navigation, Inc.-Littleton
300 Foster Street
Littleton MA 01460-2017
For Additional Information Contact
978-698-6000
Manufacturer Reason
for Recall		 O-arm O2 Surgical Imaging System Spatial calibration may be erroneous in Stealth Station navigated images
FDA Determined
Cause 2		 Software design
Action Medtronic Navigation contacted customers via telephone beginning September 23, 2016. Customers were informed of the affected product, problem and actions to be taken. Medtronic requests that users immediately discontinue the use of the O-Arm O2 Surgical Imaging system for automatic registration in Stealth Station navigated surgical procedures until further notice. Medtronic Service personnel have been scheduled to begin the necessary inspections and re-calibration activities on customer systems beginning on September 23, 2016.
Quantity in Commerce 14 units
Distribution Worldwide Distribution - US Nationwide in the states of CO, KA, NE, MI, MO, OH, WA and country of 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 = OWB and Original Applicant = MEDTRONIC INC.
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