GE Healthcare Discovery NM/CT 670 ES, Model/Catalog Numbers: 1) H3100XF ; System, Tomography, ...
FDA Device Recall #Z-0894-2025 — Class II — December 18, 2024
Recall Summary
| Recall Number | Z-0894-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 18, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
| Location | Tirat Carmel |
| Product Type | Devices |
| Quantity | 17 units |
Product Description
GE Healthcare Discovery NM/CT 670 ES, Model/Catalog Numbers: 1) H3100XF ; System, Tomography, Computed, Emission
Reason for Recall
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
Distribution Pattern
Worldwide
Lot / Code Information
1) H3100XF: UDI/DI N/A, System ID NT1011, Serial Number T2AG12009/ 88227HL4; UDI/DI N/A, System ID NT2002, Serial Number T2AG12011/ 89154HL9; UDI/DI N/A, System ID NT1009, Serial Number T2AG12013/ 90088HL6; UDI/DI N/A, System ID NT1003, Serial Number T2BG11001/ 79573HL2; UDI/DI N/A, System ID NT1004, Serial Number T2AG12003/ 79574HL0; UDI/DI N/A, System ID NT1005, Serial Number 84775HL6; UDI/DI N/A, System ID NT1020, Serial Number T2AG12012/ 89666HL2; UDI/DI N/A, System ID NT1016, Serial Number T2AG13020/ 96237HL3; UDI/DI N/A, System ID NT0002, Serial Number 106491HL4; UDI/DI N/A, System ID NT2004, Serial Number 105724HL9; UDI/DI N/A, System ID NT1012, Serial Number T2AG13016/ 93885HL2; UDI/DI N/A, System ID NT1012, Serial Number T2AG13017/ 93885HL2; UDI/DI N/A, System ID NT1013, Serial Number 94165HL8; UDI/DI N/A, System ID NT1010, Serial Number T2AG12008/ 87697HL9; UDI/DI N/A, System ID NT3001, Serial Number 85748HL2; UDI/DI N/A, System ID NT1017, Serial Number T2AG13027/ 104213HL4; UDI/DI N/A, System ID NT1015, Serial Number T2AG13018/ 94292HL0.
Other Recalls from GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL...
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1112-2026 | Class II | GE Healthcare Omni Legend, sold under the follo... | Dec 24, 2025 |
| Z-1046-2026 | Class II | SMV BodyTrack, System, Tomography, Computed... | Dec 10, 2025 |
| Z-1047-2026 | Class II | MAXXUS, System, Tomography, Computed, Emission | Dec 10, 2025 |
| Z-1044-2026 | Class II | SMV DSX New Line, System, Tomography, Compu... | Dec 10, 2025 |
| Z-1045-2026 | Class II | SMV DSI, System, Tomography, Computed, Emis... | Dec 10, 2025 |
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.