OEC 9900 Elite, OEC 9900 Elite MD Motorized C-arm System, OEC 9900 Elite NAV used as an aid to lo...
FDA Device Recall #Z-2025-2012 - Class II, November 19, 2007
Recall Summary
| Recall Number | Z-2025-2012 |
| Classification | Class II - Moderate risk |
| Date Initiated | November 19, 2007 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | GE OEC Medical Systems, Inc |
| Location | Salt Lake City, UT |
| Product Type | Devices |
| Quantity | 726 units |
Product Description
OEC 9900 Elite, OEC 9900 Elite MD Motorized C-arm System, OEC 9900 Elite NAV used as an aid to locate anatomical structures during open or percutaneous surgical procedures. 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 surgery 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 CT, MRI, or X-ray.
Reason for Recall
Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC recalled imaging devices OEC 9900, OEC 9800, and OEC 8800 as a result of an FDA inspection identifying that the vertical lift column power supply in the mainframe C-arm is defective and subject to early life failure.
Distribution Pattern
Worldwide Distribution.
Lot / Code Information
Part numbers: 00-887200-01; 00-887200-03; 00-887201-01; 00-887201-03; 00-887202-01; 00-887202-03; 00-887204-03; 00-887207-03; 00-887206-03. Along with all associated serial numbers.
Other Recalls from GE OEC Medical Systems, Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0703-2025 | Class II | OEC 3D REF Image-Intensified Fluoroscopic X... | Nov 21, 2024 |
| Z-0705-2025 | Class II | OEC 9900 REF Image-Intensified Fluoroscopic... | Nov 21, 2024 |
| Z-0704-2025 | Class II | OEC Elite REF Image-Intensified Fluoroscopi... | Nov 21, 2024 |
| Z-0706-2025 | Class II | OEC 9800 REF Image-Intensified Fluoroscopic... | Nov 21, 2024 |
| Z-2279-2023 | Class II | Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TO... | May 15, 2023 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.