Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Radiological Image Processing System The system is an aid to Recalled by GE OEC Medical Systems, Inc Due to The FluoroTrak Spinal Navigation Application on the OEC...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact GE OEC Medical Systems, Inc directly.
Affected Products
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.
Quantity: 17
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 9 states: FL, IL, IN, LA, MO, NH, NJ, PA, TX
About GE OEC Medical Systems, Inc
GE OEC Medical Systems, Inc has 48 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report