FDA Device recall Z-0900-2025
GE Healthcare Varicam Millennium VG Discovery VH, Model/Catalog Numbers: 1) ASM000085
- FDA Device
- Class II
- ongoing
- Published 2025-01-22
On 2025-01-22 the FDA classified a Class II recall of GE Healthcare Varicam Millennium VG Discovery VH, Model/Catalog Numbers: 1) ASM000085 by Ge Medical Systems Israel Functional Imaging, citing 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 Affecte….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0900-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-12-18 |
| Published | 2025-01-22 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ge Medical Systems Israel Functional Imaging |
| Distribution | n/a |
Product
GE Healthcare Varicam Millennium VG Discovery VH, Model/Catalog Numbers: 1) ASM000085; 2) ASM001092; 3) SYS000001; System, Tomography, Computed, Emission
Reason
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.
Identifiers
| code_info | 1) ASM000085: UDI/DI N/A, System ID NM10569, Serial Number 10569; UDI/DI N/A, System ID NM10570, Serial Number 10570;…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 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0900-2025%22
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