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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 Systemsee related information
Date Initiated by FirmOctober 12, 2010
Date PostedJune 21, 2012
Recall Status1 Terminated 3 on June 21, 2012
Recall NumberZ-1849-2012
Recall Event ID 61741
510(K)NumberK092564 
Product Classification System, x-ray, mobile - Product Code IZL
ProductMedtronic 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
ActionMedtronic 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 Commerce3 units
DistributionNationwide Distribution including the states of CO, IN, and MN.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = IZL
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