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U.S. Department of Health and Human Services

Enforcement Report - Week of December 26, 2013

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Product Detail

Product Description InstaTrak® 3500 Plus, ENTrakTM Plus, InstaTrak® 3500, ENTrakTM Computer-Assisted Navigation Systems (USA),
Recall Number Z-0524-2014
Classification Class II
Code Info Model Numbers IT2500,IT2500 Plus,IT3500, IT3500 Plus
Product Distributed Qty 654
Reason For Recall GE OEC Medical Systems Inc is recalling InstaTrak® 3500 Plus, ENTrakTM Plus, InstaTrak® 3500, ENTrakTM Computer-Assisted Navigation Systems (USA) due to several potential safety issues related to the use of these products.

Event Detail

Event Id 66992
Product Type Devices
Status Ongoing
Recalling Firm GE OEC Medical Systems, Inc
City Salt Lake City
State UT
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-11-26
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution
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