FDA Device recall Z-0897-2025
GE Healthcare Infinia II, Model/Catalog Numbers: 1) H2799ZP
- FDA Device
- Class II
- ongoing
- Published 2025-01-22
On 2025-01-22 the FDA classified a Class II recall of GE Healthcare Infinia II, Model/Catalog Numbers: 1) H2799ZP 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-0897-2025 |
| 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 Infinia II, Model/Catalog Numbers: 1) H2799ZP; 2) H3000WT; 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) H2799ZP: UDI/DI N/A, System ID A5109665, Serial Number 16611; 2) H3000WT: UDI/DI N/A, System ID 205408NUC, Seria…1) H2799ZP: UDI/DI N/A, System ID A5109665, Serial Number 16611; 2) H3000WT: UDI/DI N/A, System ID 205408NUC, Serial Number 17419; UDI/DI N/A, System ID 256341NRM1, Serial Number 18226; UDI/DI N/A, System ID 256494NM1, Serial Number 17133; UDI/DI N/A, System ID 256543INF1, Serial Number 17182; UDI/DI N/A, System ID 205408INF2, Serial Number 18157; UDI/DI N/A, System ID 256429INF1, Serial Number 17557; UDI/DI N/A, System ID 256327NUC, Serial Number 17900; UDI/DI N/A, System ID 334418INF, Serial Number 17266; UDI/DI N/A, System ID 256386HKNM2, Serial Number 16970; UDI/DI N/A, System ID 205750INF, Serial Number 16802; UDI/DI N/A, System ID 501776INF, Serial Number 17294; UDI/DI N/A, System ID 479463INF2, Serial Number 16900; UDI/DI N/A, System ID 501202INF, Serial Number 16564; UDI/DI N/A, System ID 479967INF, Serial Number 16817; UDI/DI N/A, System ID 479549INF, Serial Number 18319; UDI/DI N/A, System ID 479751INF, Serial Number 16800; UDI/DI N/A, System ID 928214INF, Serial Number 1 |
|---|
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-0897-2025%22
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