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U.S. Department of Health and Human Services

Enforcement Report - Week of June 27, 2012

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Product Detail

Product Description 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.
Recall Number Z-1849-2012
Classification Class II
Code Info Serial Numbers: 125, 156, 234R.
Product Distributed Qty 3 units
Reason For Recall Software Version 3.1.1 does not meet navigational accuracy.

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.