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U.S. Department of Health and Human Services

Enforcement Report - Week of June 27, 2012

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Event Detail

Event ID 61741
Product Type Devices
Status Terminated
Recalling Firm Medtronic Navigation, Inc.
City Littleton
State MA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2010-10-12
Initial Firm Notification of
Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Nationwide Distribution including the states of CO, IN, and MN.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and BI-700-00027-120. The 0-armĀ® Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging. Serial Numbers: 125, 156, 234R. Class II Software Version 3.1.1 does not meet navigational accuracy. 3 units Z-1849-2012