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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Navigation OArm Imaging System

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 Class 2 Recall
Medtronic Navigation OArm Imaging System
see related information
Date Posted November 23, 2010
Recall Status1 Terminated on June 04, 2012
Recall Number Z-0447-2011
Recall Event ID 57048
Premarket Notification
510(K) Number
K092564 
Product Classification System, X-Ray, Mobile - Product Code IZL
Product Medtronic Navigation O-Arm Imaging System, Door Assembly (BI-700-00006) used in Product Catalog Numbers: 9732719,9733346,81-700-00027, 81-700-00027R, 81700- 00027-100, 81-700-00027-1 OOR, 81-700-00027-120, 81-700-00027-120R, 81700-00027-230, 81-700-00027-230R, 81-700-00027GER, 81-700-00027GERR Intended use: Designed for 2D fluoroscopic and 3D imaging and is intended to be used by a physician benefits from 2D and 3D information of anatomic structures with high x-ray attenuation such as bony and metallic objects.
Code Information All Units distributed from June 2006 through September 2010
Recalling Firm/
Manufacturer
Medtronic Navigation, Inc.
300 Foster St
Littleton, Massachusetts 01460-2017
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact SAME
978-339-6426
Manufacturer Reason
for Recall
Safety Notice: Door Cable Periodic Maintenance Schedule and Cable Wear for the O-ARM¿¿ Imaging System Breakage of the door cable during opening and closing may occur and cause physical harm or delay of therapy
FDA Determined
Cause 2
PRODUCTION CONTROLS: Equipment Maintenance
Action Medtronic Navigation sent all consignees/customers an "Urgent Field Safety Notice" letter dated October 15, 2010. The letter described the product, problem and action to be taken by the customers. The customers were instructed to review and follow the attached information that describes the process to properly detect and proactively manage cable wear; to ensure that the door is completely open when positioning the patient into or removing them from the gantry and when placing the O-ARM Imaging System Tube Drape (BI-900-00003) onto the unit, and report any visual or audible (cracking noise) wear of the cable to Medtronic Representative ASAP. Note: A Medtronic Representative will be contacting the customers within the coming weeks to schedule a time to inspect the current condition of the cable, explain and train the customers on the recommended workflow and inspection procedure and place a permanent label on their O-ARM Imaging System to reinforce these actions. 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 720-890-3200.
Quantity in Commerce 244 units
Distribution Worldwide distribution: USA including states of: AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, and WI; and countries including: Canada, Austria, Australia, Belgium, Brazil, Libya, South Africa, India, Japan, Singapore South Korea, Haiti, Kuwait, Saudi Arabia, Turkey, UAE, Germany, Netherlands, Great Britain, Italy, Poland, Netherlands, Spain,Sweden, and Switzerland.
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.
510(K) Database 510(K)s with Product Code = IZL and Original Applicant = MEDTRONIC NAVIGATION, INC. (LITTLETON)
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