FDA Device recall Z-1787-2013
GE Healthcare Infinia Hawkeye 4 Option For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for Dual-Head Variable Angle Gamma Camera…
- FDA Device
- Class I
- terminated
- Published 2013-07-31
On 2013-07-31 the FDA classified a Class I recall of GE Healthcare Infinia Hawkeye 4 Option For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for Dual-Head Variable Angle Gamma Camera… 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-1787-2013 |
| 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 Infinia 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 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: 1153389, 1299296, 2555007, 2621801, 2638808, 2694593, 2760723, 2768147, 2769200, 2775945, 2812777, 2827087,…System ID: 1153389, 1299296, 2555007, 2621801, 2638808, 2694593, 2760723, 2768147, 2769200, 2775945, 2812777, 2827087, 2883051, 0828260003, 0828260005, 0828260006, 0828260007, 0828260009, 0828260011, 0828260013, 0828260015, 0828260017, 0828260018, 0828260019, 0828260020, 0834260003, 0834260008, 0834260012, 835260007, 0835260010, 0835260013, 0843260029, 0843260032, 0843260034, 0843260037, 0843260044, 0843260047, 0843260048, 0847260025, 0850260060, 0850260061, 0850260063, 0850260064, 0850260065, 0850260066, 0850260067, 0850260068, 0850260069, 0850260070, 0850260073, 0850260074, 0850260075, 0850260076, 0850260077, 0850260079, 0850260080, 0850260081, 0850260082, 0850260083, 0850260084, 0850260087, 0850260088, 0850260089, 0850260090, 0850260091, 0850260092, 0850260093, 0850260094, 0850260095, 0850260096, 0850260098, 0850260099, 0850260100, 0850260103, 0850260104, 0850260105, 0850260106, 0850260107, 0850260108, 0850260109, 0850260110, 0850260111, 0850260112, 0850260113, 0850260114, 08502601 |
|---|
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-1787-2013%22
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