Product Wiki · Recalls · U.S. FDA — Device Enforcement

Radiological Image Processing System The system is an aid to locate… — recall Z-2136-2012

U.S. FDA — Device Enforcement · United States · 2007-04-02 · Class I

As described by U.S. FDA — Device Enforcement: 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 anato

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2136-2012
Date of alert
2007-04-02
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
GE OEC Medical Systems, Inc
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide Distribution - USA including MO, IL, LA, FL, NH, TX, IN, PA, NJ and the countries of France and China
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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