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U.S. Department of Health and Human Services

Enforcement Report - Week of August 15, 2012

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Product Detail

Product Description Radiological Image Processing System The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgical technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visible on medical images such as CS, MR, or X-ray.
Recall Number Z-2136-2012
Classification Class I
Code Info E9-0002-G, ES-0013-G, E9-0036-G, E9-0040-G, E9-0041-G, ES-0014-G, ES-0016-G, ES-0033-G, ES-0043-G, ES-0041-G, ES-0042-G, ES-OO84-G, ES-0086-G, ES-0163-G, E9-0089-G, ES-0026-G, ES-0044-G
Product Distributed Qty 17
Reason For Recall The FluoroTrak Spinal Navigation Application on the OEC 9900 EliteNAV could result in an incorrect position of the navigated instrument(s) versus the displayed reference image.

Event Detail

Event Id 62414
Product Type Devices
Status Completed
Recalling Firm GE OEC Medical Systems, Inc
City Salt Lake City
State UT
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2007-04-02
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA including MO, IL, LA, FL, NH, TX, IN, PA, NJ and the countries of France and China