FDA Device recall Z-2097-2025
Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system
- FDA Device
- Class II
- ongoing
- Published 2025-07-16
On 2025-07-16 the FDA classified a Class II recall of Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system by Ge Medical Systems Israel Functional Imaging, citing unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed. Unintended detector m….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2097-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-06-20 |
| Published | 2025-07-16 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ge Medical Systems Israel Functional Imaging |
| Distribution | US |
Product
Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system
Reason
Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed. Unintended detector motion may result in life-threatening injury.
Identifiers
| code_info | Serial Numbers: Infinia I 16143 16149 16179 16315 16335 16353 16826 17339 17799 18420 18442 18604 18605 18611 18624 18…Serial Numbers: Infinia I 16143 16149 16179 16315 16335 16353 16826 17339 17799 18420 18442 18604 18605 18611 18624 18627 18628 18629 18637 18639 18641 18644 18645 18647 18648 18649 18650 18651 18652 18653 18655 18656 18657 193S08002; Infinia I Hawkeye 1 15006 15007 15013 16001 16003 16004 16005 16006 16007 16008 16009 16011 16012 16013 16015 16016 16019 16021 16022 16024 16026 16027 16028 16030 16033 16037 16038 16039 16043 16044 16048 16049 16050 16051 16052 16054 16057 16059 16060 16063 16064 16065 16070 16073 16074 16079 16081 16082 16083 16084 16087 16091 16099 16107 16109 16114 16123 16126 16127 16132 16134 16137 16140 16141 16148 16151 16153 16154 16155 16158 16159 16163 16164 16166 16168 16169 16171 16172 16173 16175 16177 16178 16182 16186 16433; Infinia II 16045 16094 16115 16135 16170 16190 16191 16194 16196 16198 16206 16207 16208 16209 16211 16212 16213 16214 16218 16220 16221 16223 16224 16227 16228 16229 16234 16235 16239 16244 16246 16250 16259 16262 16263 16271 1627 |
|---|
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-2097-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.