FDA Device recall Z-1793-2013
Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of…
- FDA Device
- Class I
- terminated
- Published 2013-07-31
On 2013-07-31 the FDA classified a Class I recall of Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of… 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-1793-2013 |
| 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
Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine (NM) system using a variety of scanning modes supported by various acquisition types, and a CT component which is intended specifically for enabling attenuation correction and anatomical localization on SPECT studies
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: 0910263253, 0910263256, 00139NUC08, 00162NUC11, 030232NU15, 215728OPT640, 262574O640, 270956NM640, 410543NUC…System ID: 0910263253, 0910263256, 00139NUC08, 00162NUC11, 030232NU15, 215728OPT640, 262574O640, 270956NM640, 410543NUC640, 715735OPT1, 717782640NM, 808485NM640, 815564O640, 816234D640, 817250NM640, 847872O640, 901516GO640, 915839NU01, 928214NMCT, A5366308, A5639613, BD003NU01, DK1054NM03, RTD0782, XM203401. |
|---|
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-1793-2013%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.