FDA Device recall Z-1792-2013
Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system
- FDA Device
- Class I
- terminated
- Published 2013-07-31
On 2013-07-31 the FDA classified a Class I recall of Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system 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-1792-2013 |
| 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
Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy.
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. UPDATE: On July 03, 2013 GE notified hospitals that they are recalling several Nuclear Medicine Imaging Systems because serious injuries or deaths could occur due to the failure mode associated with this re
Identifiers
| code_info | System ID: 0828260021, 0828260022, 0850260118, 0850260122, 0850260128, 0850260131, 0850260132, 0853260094, 0853260099,…System ID: 0828260021, 0828260022, 0850260118, 0850260122, 0850260128, 0850260131, 0850260132, 0853260094, 0853260099, 0856260033, 0856260034, 0856260035, 0910262297, 0910262304, 0910262310, 0910262319, 0910262322, 0910262325, 0910262344, 0910263223, 0910263228, 0910263231, 0910263235, 0910263239, 0910263241, 0910263243, 0910263250, 0910264135, 0910264141, 0910264147, 0910265074, 0910265075, 0910265076, 0920269097, 082426040043, 082426040044, 082426060005, 082426070028, 082426070030, 082426080020, 082426090029, 082426090030, 082426130029, 082426130030, 082426150026, 082426160042, 082426210020, 082426230020, 083026009408410, 083026023683711, 083026201006810, 00001NUC12, 00028NUC01, 00042NUC02, 00046NUC06, 00065NUC08, 00123NUC01, 00149NUC01, 00149NUC03, 00197NUC14, 00199NUC13, 00200NUC07, 00200NUC08, 00234NUC09, 00361NUC08, 00432NUC02, 010120NU19, 030037NU08, 030082NU13, 030133NU13, 030360NU01, 05462NUC05, 06007NUC19, 080041NU04, 100032NU05, 10497NUC20, 110017NU06, 110022NU05, 11018NUC08 |
|---|
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-1792-2013%22
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