FDA Device recall Z-0888-2025
GE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, 3) H3000WM, 4) H3000YG
- 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, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, 3) H3000WM, 4) H3000YG 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-0888-2025 |
| 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, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, 3) H3000WM, 4) H3000YG; 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) 5178728: UDI/DI N/A, System ID YN1200, Serial Number: 16179; System ID YN1650, Serial Number: 17339. 2) H300…1) 5178728: UDI/DI N/A, System ID YN1200, Serial Number: 16179; System ID YN1650, Serial Number: 17339. 2) H3000WE: UDI/DI N/A, System ID 82426060010, Serial Number Not Available; System ID 82426080021, Serial Number Not Available; System ID 82426090035, Serial Number 18605; System ID 82426090037, Serial Number 18604; System ID 82426100057, Serial Number 19191; System ID 82426150036, Serial Number 18624; System ID 82426150038, Serial Number Not Available; System ID 82426180015, Serial Number 18611; System ID 082426010021, Serial Number 18644; System ID 082426030032, Serial Number 18627; System ID 082426050012, Serial Number 18629; System ID 082426070041, Serial Number 18639; System ID 082426090044, Serial Number 18652; System ID 082426100067, Serial Number 18648; System ID 082426100069, Serial Number 18641; System ID 082426120031, Serial Number 18656; System ID 082426120033, Serial Number 18650; System ID 082426140029, Serial Number 18628; System ID 082426140030, Serial Numbe |
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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-0888-2025%22
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