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. |
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| 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 |
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