GE Healthcare Varicam Millennium VG Discovery VH, Model/Catalog Numbers: 1) ASM000085; 2) AS...
FDA Device Recall #Z-0900-2025 — Class II — December 18, 2024
Recall Summary
| Recall Number | Z-0900-2025 |
| 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 | 30 units |
Product Description
GE Healthcare Varicam Millennium VG Discovery VH, Model/Catalog Numbers: 1) ASM000085; 2) ASM001092; 3) SYS000001; 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) ASM000085: UDI/DI N/A, System ID NM10569, Serial Number 10569; UDI/DI N/A, System ID NM10570, Serial Number 10570; UDI/DI N/A, System ID YN0845, Serial Number 10242; UDI/DI N/A, System ID YN0498, Serial Number 1092; UDI/DI N/A, System ID YN0440, Serial Number 1003; UDI/DI N/A, System ID 979764VGH1, Serial Number 77521848; UDI/DI N/A, System ID NM10225, Serial Number 10225. 2) ASM001092: UDI/DI N/A, System ID 310231VGH1, Serial Number 10539; UDI/DI N/A, System ID 207795VH, Serial Number 10571; UDI/DI N/A, System ID 82426070015, Serial Number 10550; UDI/DI N/A, System ID 82426210010, Serial Number 10595; UDI/DI N/A, System ID 82426280001, Serial Number 10591; UDI/DI N/A, System ID 082426080009, Serial Number 10599; UDI/DI N/A, System ID H2103NUC06, Serial Number 10582; UDI/DI N/A, System ID H1404NUC06, Serial Number 10604; UDI/DI N/A, System ID H2094NUC07, Serial Number 10587; UDI/DI N/A, System ID YN0984, Serial Number 10543; UDI/DI N/A, System ID 850260054, Serial Number 10579; UDI/DI N/A, System ID RU1591NM01, Serial Number 10561; UDI/DI N/A, System ID RU1457NM01, Serial Number 10553; UDI/DI N/A, System ID 209526MILVG, Serial Number 10340; UDI/DI N/A, System ID 416469DVH, Serial Number 10384; UDI/DI N/A, System ID CY1088MN04, Serial Number 10360; UDI/DI N/A, System ID Not Available, Serial Number 81251648; UDI/DI N/A, System ID B5315325, Serial Number 10185. 3) ASM001099: UDI/DI N/A, System ID PER10925, Serial Number 10346. 4) SYS000001: UDI/DI N/A, System ID NM10374, Serial Number 10374; UDI/DI N/A, System ID NM10147, Serial Number 10147; UDI/DI N/A, System ID 334794MILVG, Serial Number 1063; UDI/DI N/A, System ID NM10291, Serial number 10291; UDI/DI N/A, System ID 56948, Serial number 1021. 5) SYS000002: UDI/DI N/A, System ID 949760VG1, Serial Number 10445; UDI/DI N/A, System ID NM10174, Serial Number 10174; UDI/DI N/A, System ID 223410MILVG, Serial Number 1069. 6) SYS000003: UDI/DI N/A, System ID 914734VG, Serial number 10435.
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.