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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 Recall
OArm Imaging system
see related information
Date Posted July 13, 2010
Recall Status1 Terminated on October 07, 2011
Recall Number Z-1998-2010
Recall Event ID 55675
Premarket Notification
510(K) Numbers
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, Massachusetts 01460-2017
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
The possibility that the real time image display can freeze up during use of a 2D continuous fluoroscopy.
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 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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