FDA Device recall Z-1788-2013
GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine…
- FDA Device
- Class I
- terminated
- Published 2013-07-31
On 2013-07-31 the FDA classified a Class I recall of GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine… by Ge Healthcare, citing GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1788-2013 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2013-06-13 |
| Published | 2013-07-31 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
GE Healthcare Varicam/VG and VG Hawkeye 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 typed and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT, Gated SPECT, Whole body SPECT, Camera based PET). Acquisition types include single and multi-isotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation correction and functional anatomic mapping.
Reason
GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System.
Identifiers
| code_info | System ID: 2998, 6970, 12865, 21414, 38070, 53263, 55461, 56948, 58230, 58378, 58379, 58483, 58510, 58582, 58622, 5863…System ID: 2998, 6970, 12865, 21414, 38070, 53263, 55461, 56948, 58230, 58378, 58379, 58483, 58510, 58582, 58622, 58630, 58711, 58785, 58797, 58808, 58810, 58871, 58883, 58919, 58958, 58993, 59012, 61061, 63422, 66515, 75074, 79722, 79966, 84636, 92635, 99691, 0850260033, 0850260034, 0850260035, 0850260038, 0850260040, 0850260041, 0850260042, 0850260046, 0850260048, 0850260054, 0850260057, 0850260062, 0853940029, 0853940068, 0853940069, 0853940077, 0853940078, 0853940080, 0853940082, 0856260014, 0856260019, 0910265011, 0910453006, 082426010009, 082426010010, 082426010011, 082426020002, 082426030009, 082426030010, 082426030015, 082426030016, 082426030018, 082426040016, 082426040020, 082426040021, 082426040024, 082426040025, 082426040026, 082426040029, 082426050001, 082426050002, 082426050003, 082426070014, 082426070015, 082426070016, 082426080006, 082426080007, 082426080009, 082426090013, 082426100017, 082426100019, 082426100020, 082426100023, 082426110002, 082426120003, 082426120004, |
|---|
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-1788-2013%22
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