FDA Device recall Z-0899-2025
GE Healthcare Infinia II Hawkeye 4, Model/Catalog Numbers: 1) H2799PP
- 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 Hawkeye 4, Model/Catalog Numbers: 1) H2799PP 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-0899-2025 |
| 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 Hawkeye 4, Model/Catalog Numbers: 1) H2799PP; 2) H2799PR; 3) H2799YC; 4) H2799YD; 5) H3000WC; 6) H3000WD; 7) H3000WT; 8) H3000WW; 9) H3000WY; 10) H3000WZ; 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) H2799PP: UDI/DI N/A, System ID 850260060, Serial Number 16130. 2) H2799PR: UDI/DI N/A, System ID 217347INF2,…1) H2799PP: UDI/DI N/A, System ID 850260060, Serial Number 16130. 2) H2799PR: UDI/DI N/A, System ID 217347INF2, Serial Number 17325. 3) H2799YC: UDI/DI N/A, System ID M54606103, Serial Number 16846. 4) H2799YD: UDI/DI N/A, System ID M348992912, Serial Number 17033. 5) H3000WC: UDI/DI N/A, System ID 907562HK4, Serial Number 18610; UDI/DI N/A, System ID 907562HK4, Serial Number 18643; UDI/DI N/A, System ID 205783INF1, Serial Number 17571; UDI/DI N/A, System ID 479553INF, Serial Number 18470; UDI/DI N/A, System ID 479441INF1, Serial Number 17301; UDI/DI N/A, System ID 928855INF, Serial Number 17190; UDI/DI N/A, System ID 480512INF1, Serial Number 17019; UDI/DI N/A, System ID 602406INF1, Serial Number 18422; UDI/DI N/A, System ID 602406INF3, Serial Number 18465; UDI/DI N/A, System ID 480323INFRM3, Serial Number 17488; UDI/DI N/A, System ID 480882INF1, Serial Number 18026; UDI/DI N/A, System ID 530888IN1, Serial Number 18579; UDI/DI N/A, System ID 760873NUC, Serial Num |
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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-0899-2025%22
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