FDA Device recall Z-2136-2012
Radiological Image Processing System The system is an aid to locate anatomical structures during open or percutaneous surgical procedures
- FDA Device
- Class I
- terminated
- Published 2012-08-15
On 2012-08-15 the FDA classified a Class I recall of Radiological Image Processing System The system is an aid to locate anatomical structures during open or percutaneous surgical procedures by Ge Oec Medical Systems, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2136-2012 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2007-04-02 |
| Published | 2012-08-15 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Oec Medical Systems |
| Distribution | FL, IL, IN, LA, MO, NH, NJ, PA, TX |
Product
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.
Reason
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.
Identifiers
| 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…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Ge Oec Medical Systems
- OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile
FDA Device · Class II · 2024-12-25 · Ge Oec Medical Systems - OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile
FDA Device · Class II · 2024-12-25 · Ge Oec Medical Systems - OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile
FDA Device · Class II · 2024-12-25 · Ge Oec Medical Systems - OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile
FDA Device · Class II · 2024-12-25 · Ge Oec Medical Systems - OEC Flexiview 8800 Systems with 9-inch Image Intensifier
FDA Device · Class II · 2023-08-09 · Ge Oec Medical Systems
All Ge Oec Medical Systems recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2136-2012%22
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