The Discovery NM/CT 570c CT Standalone Scan The Discovery NM/CT 570c… — Class II medical device recall Z-1967-2013
Terminated recall by GE Healthcare, LLC, reported 2013-08-28. GE Healthcare has recently become aware of an incident where the wrong part of the patient body was scanned du
| Recall number | Z-1967-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2013-04-10 |
| Classified | 2013-08-20 |
| Reported by FDA | 2013-08-28 |
| Terminated | 2014-01-21 |
| Quantity | 10 systems |
| Model numbers | H3000SAUFC |
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 for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1967-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.