FDA Device recall Z-0898-2025
GE Healthcare Infinia I Hawkeye 1, Model/Catalog Numbers: 1) H3000WN
- FDA Device
- Class II
- ongoing
- Published 2025-01-22
On 2025-01-22 the FDA classified a Class II recall of GE Healthcare Infinia I Hawkeye 1, Model/Catalog Numbers: 1) H3000WN 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-0898-2025 |
| 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 I Hawkeye 1, Model/Catalog Numbers: 1) H3000WN; 2) H3000YM; 3) H3000YS; 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) H3000WN: UDI/DI N/A, System ID YN1593, Serial Number 16433. 2) H3000YM: UDI/DI N/A, System ID 602406INF, Serial…1) H3000WN: UDI/DI N/A, System ID YN1593, Serial Number 16433. 2) H3000YM: UDI/DI N/A, System ID 602406INF, Serial Number 16012; UDI/DI N/A, System ID 928537INF, Serial Number 16021; UDI/DI N/A, System ID 661633NM1, Serial Number 15013; UDI/DI N/A, System ID 661633NM1, Serial Number 16051; UDI/DI N/A, System ID 619482INFINIA, Serial Number 16007; UDI/DI N/A, System ID 626359INF2, Serial Number 16175; UDI/DI N/A, System ID 626359INF1, Serial Number 16177; UDI/DI N/A, System ID 916983INFN1, Serial Number 16059; UDI/DI N/A, System ID 858554INF1, Serial Number 16169; UDI/DI N/A, System ID 858554INF2, Serial Number 16186; UDI/DI N/A, System ID 626570INF1, Serial Number 16030; UDI/DI N/A, System ID 310543INF1, Serial Number 16006; UDI/DI N/A, System ID 303320IH, Serial Number 16013; UDI/DI N/A, System ID 860350INIF, Serial Number 16065; UDI/DI N/A, System ID 863687INF1, Serial Number 16182; UDI/DI N/A, System ID 941629INF, Serial Number 16026; UDI/DI N/A, System ID 630801INF, Serial Numb |
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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-0898-2025%22
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