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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 October 12, 2010
Date Posted June 21, 2012
Recall Status1 Terminated 3 on June 21, 2012
Recall Number Z-1849-2012
Recall Event ID 61741
510(K)Number K092564  
Product Classification System, x-ray, mobile - Product Code IZL
Product Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and BI-700-00027-120. The 0-arm¿ Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging.
Code Information Serial Numbers: 125, 156, 234R.
Recalling Firm/
Manufacturer		 Medtronic Navigation, Inc.
300 Foster St
Littleton MA 01460-2017
For Additional Information Contact
978-698-6008
Manufacturer Reason
for Recall		 Software Version 3.1.1 does not meet navigational accuracy.
FDA Determined
Cause 2		 Software design
Action Medtronic Navigation contacted customers by telephone on 10/12/2010 and with "Urgent Field Safety Notice" follow up letters dated 10/14 or 10/15/2010. Sites were visited by Medtronic Service Representative to complete navigational accuracy testing and either replace or correct the unit.
Quantity in Commerce 3 units
Distribution Nationwide Distribution including the states of CO, IN, and MN.
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 = IZL and Original Applicant = MEDTRONIC NAVIGATION, INC. (LITTLETON)
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