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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 June 21, 2012
Recall Status1 Terminated on June 21, 2012
Recall Number Z-1849-2012
Recall Event ID 61741
Premarket Notification
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, Massachusetts 01460-2017
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Software Version 3.1.1 does not meet navigational accuracy.
FDA Determined
Cause 2
DESIGN: 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 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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