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.
FDA Recall Z-2136-2012 · Posted 2012-08-08
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Recalling FirmGE OEC Medical Systems, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2007-04-02
Date Terminated2012-09-28
Product Quantity17
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.
Firm Action
GE Healthcare sent an Urgent Recall Notice dated April 2, 2007, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers with questions were asked to call 800-874-7378. For questions regarding this recall call 801-536-4952,
Root Cause
Software design
Distribution Pattern
Worldwide Distribution - USA including MO, IL, LA, FL, NH, TX, IN, PA, NJ and the countries of France and China
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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