InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System, Model Num...
FDA Device Recall #Z-1985-2012 - Class I, September 15, 2006
Recall Summary
| Recall Number | Z-1985-2012 |
| Classification | Class I - Serious risk |
| Date Initiated | September 15, 2006 |
| Status | Terminated |
| Voluntary | FDA Mandated |
Recalling Firm
| Firm | GE OEC Medical Systems, Inc |
| Location | Salt Lake City, UT |
| Product Type | Devices |
| Quantity | 86 units |
Product Description
InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System, Model Number IT3500 Plus. Product Usage: Usage: 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 CT, MR, 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. On October 11, 2006, GE Healthcare recalled GE OEC InstaTrak 3500 Plus System with Software version 5.2, the surgical Navigation and Visualization Application due to software related issues.
Distribution Pattern
Worldwide Distribution - US (nationwide)
Lot / Code Information
IT35050P, IT35071, IT35129, IT35133, IT35134, IT35139, IT35140, IT35143P-RC, IT35144P, IT35145P-RC, IT35146, IT35147P-RC, IT35148, IT35150, IT35153P, IT35156, IT35161, IT35162P-RC, IT35164, IT35169P-RC, IT35170G-RC, IT35175, IT35182G-RC, IT35183P-RC, IT35186P, IT35187P, IT35189P, IT35192P, IT35193P, IT35194P, IT35195P, IT35200P, IT35201P, IT35207P, IT35208P, IT35209P, IT35211P-RC, IT35214P, IT35215P, IT35220P, IT35222P, IT35223P, IT35225P, IT35228P, IT35231P, IT35232P, IT35234P, IT35236P, IT35237P, IT35240P, IT35242P, IT35245P, IT35248P, IT35251P, IT35252P, IT35253P, IT35263P, IT35265P, IT35269P, IT35270P, IT35271P, IT35273P, IT35274P, IT35277P, IT35280P, IT35284P, IT35285P, IT35290P, IT35293P, IT35294P, IT35295P, IT35296G, IT35297P, IT35299P, IT35300P, IT35302P, IT35303P, IT35304P, IT35309G, IT35310P, IT35311P, IT35312P, IT35315P, IT35316P, IT35322P, IT35323P, IT35324P, IT35330P, IT35331P, IT35334P, IT35341G, IT35342G, IT35344, IT35348P, IT35350P, IT35351P, IT35352P, IT35360P, IT35364P-RC, IT35365P, IT35367P, IT35372P, IT35377P, IT35380P, IT35383P.
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
A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.
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.