FDA Device recall Z-1967-2013
The Discovery NM/CT 570c CT Standalone Scan The Discovery NM/CT 570c hybrid system is a combination of a cardiac dedicated nuclear imaging…
- FDA Device
- Class II
- terminated
- Published 2013-08-28
On 2013-08-28 the FDA classified a Class II recall of The Discovery NM/CT 570c CT Standalone Scan The Discovery NM/CT 570c hybrid system is a combination of a cardiac dedicated nuclear imaging… by Ge Healthcare, citing GE Healthcare has recently become aware of an incident where the wrong part of the patient body was scanned during a CT standalone exam with the Discovery NM/CT 570c.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1967-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-04-10 |
| Published | 2013-08-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | CT |
Product
The Discovery NM/CT 570c CT Standalone Scan The Discovery NM/CT 570c hybrid system is a combination of a cardiac dedicated nuclear imaging subsystem and LightSpeed GE CT subsystem. This system is intended for cardiac Nuclear Medicine (NM) diagnostic imaging applications, head and body CT diagnostic imaging applications, as well as attenuation correction and anatomical localization. The Discovery product is a SPECT-CT system. It consists of two back-to-back gantries, the NM Gantry, carrying solid state Cadmium Zinc Telluride (CZT) detectors, the CT Gantry, a single patient table, power distribution unit (PDU), NMV integrated power supply (IPS) , two operator consoles with two acquisition systems (Nuclear and CT), interconnecting cables and associated accessories (ECG gating, etc.).
Reason
GE Healthcare has recently become aware of an incident where the wrong part of the patient body was scanned during a CT standalone exam with the Discovery NM/CT 570c
Identifiers
| code_info | Part numbers H3000SA UFC Cardiac SPECT System, H3001JA UFC Gantry, H3001JE UFC VCT Connecting Kit, H3001JF DISCOVERY NMV/CT 570C Connecting Kit. |
|---|
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-1967-2013%22
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