FDA Device recall Z-0184-2015
GE Healthcare Infinia (including Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye, Infinia II Hawkeye 4, Infinia II VC, Infinia II…
- FDA Device
- Class II
- terminated
- Published 2014-11-19
On 2014-11-19 the FDA classified a Class II recall of GE Healthcare Infinia (including Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye, Infinia II Hawkeye 4, Infinia II VC, Infinia II… by Ge Healthcare, citing GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the c….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0184-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-10-14 |
| Published | 2014-11-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
GE Healthcare Infinia (including Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye, Infinia II Hawkeye 4, Infinia II VC, Infinia II VC Hawkeye, and Infinia II VC Hawkeye 4) Models: H3000WC, H3000WD, H3000WE, H3000WM, H3000WN, H3000WP, H3000WR, H3000WT, H3000WW, H3000WY, H3000WZ, H3000YF, H3000YG, H3000YM, H3000YS, H2400YJ, H2400YK. Hawkeye 4 Option For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for Dual-Head Variable Angle Gamma Camera (this includes GE Quasar Nuclear Medicine Systems). Nuclear Medicine Systems Infinia devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications.
Reason
GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems.
Identifiers
| code_info | 15012 919684INF1 16089 319356INF 16168 801562JVH02 16074 519749INFINIA2 16061 82426040033 16076 82426040030 16085…15012 919684INF1 16089 319356INF 16168 801562JVH02 16074 519749INFINIA2 16061 82426040033 16076 82426040030 16085 82426310015 16158 DK1029NM05 16067 FI1023MN02 16068 FI1153MN01 16141 A5152964 16056 NO1088MN09 16152 00053NUC06 16001 906776INF 16005 615768SCNM1 16015 717782INF 16018 907562NM1 16033 318681INFINIA 16036 920738INF 16043 210921NM1 16045 941637INF 16051 507345INF1 16054 630801INF 16065 860350INIF 16071 763UNTYINFI 16075 937328INF2 16083 973625INFINIA 16084 518828INF 16088 908522INFINIA 16098 203325INF2 16111 956350NM1 16118 814533INF 16123 716366INF 16162 704783INFI3 16166 717627INFINIA 16436 203325INF 16140 110034NU04 16022 905372INFINIA 16039 905731INFINIA 16044 519749INFINIA 16072 450654INF2 16016 M2269829 16092 V2728105 16114 S4160059 16079 783348NU01 16017 HU1039NM02 16126 83026602101643 16135 A5172907 16142 A5197927 16115 850260061 16130 850260060 16170 850260063 18130 2919654INF 16019 MA1154NM02 16106 O005NU14 1604 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0184-2015%22
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