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U.S. Department of Health and Human Services

Class 2 Device Recall OArm Imaging system

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  Class 2 Device Recall OArm Imaging system see related information
Date Initiated by Firm May 10, 2010
Date Posted July 13, 2010
Recall Status1 Terminated 3 on October 07, 2011
Recall Number Z-1998-2010
Recall Event ID 55675
510(K)Number K050996  K060344  
Product Classification system, image processing, radiological - Product Code LLZ
Product O-Arm Imaging System

The O-Arm imaging system is a mobile X-Ray system designed for medical applications in surgical theaters, focusing on 3D imaging but also offering 2D fluoroscopic Imaging.
Code Information Product Catalog Number: 9732719, 9733346, BI-700-00027-100, BI-70000027-120, BI-700-00027-230
Recalling Firm/
Manufacturer		 Medtronic Navigation, Inc.
300 Foster St
Littleton MA 01460-2017
For Additional Information Contact
978-698-6008
Manufacturer Reason
for Recall		 The possibility that the real time image display can freeze up during use of a 2D continuous fluoroscopy.
FDA Determined
Cause 2		 Device Design
Action The firm, Medtronic, Inc., sent an "Urgent Field Safety Notice" letter dated May 10, 2010, to all custmers. The letter describes the product, problem and actions to be taken by customer. The firm recommended that the users of the O-Arm Imaging System reveiw the information provided to ensure patient safety remains uncompromised during use of the product. The customers were instructed to discontinue use and contact your local Medtronic Navigation representative or call our Technical Services Group at 800-595-9709 or (702) 890-3200, if the image is not updating as expected. A Medtronic Navigation representative will be contacting you within the coming months to schedule a time to evaluate and service the potentially affected components within your system. A service visit will also be scheduled starting November 2010 to update your system with a software based solution that will prevent this issue from occuring. If you have any questions about this notification, please contact your local Medtronic Navigation representative or call our Technical Services Group at 800-595-9709 or (702) 890-3200.
Quantity in Commerce 221
Distribution Worldwide distribution: USA and countries of Germany, Singapore, South Africa, Poland, Libya, Belgium, Switzerland, Turkey, Italy, Denmark, France, Spain, Finland, Czech Republic, Ireland, Slovakia, the NetherLands, Austria, UAE, Kuwait, Israel, Australia, Sweden, Canada, South Korea, Japan and India.
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 = LLZ and Original Applicant = BREAKAWAY IMAGING, LLC
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