Z-1967-2013Class II

The Discovery NM/CT 570c CT Standalone Scan The Discovery NM/CT 570c hybrid system is a combination of a...

Name: Z-1967-2013 The Discovery NM/CT 570c CT Standalone Scan The Discovery NM/CT 570c hybrid system is a combination of a...
Creator: GE Healthcare, LLC
Published: 2013-04-10
License: https://open.fda.gov/license/

GE Healthcare / initiated 2013-04-10 / Terminated

FDA source

GE Healthcare, LLC began a 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 subsystem and... on 2013-04-10. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1967-2013
Classification: Class II
Status: Terminated
Initiated: 2013-04-10
Posted: 2013-08-20
Terminated: 2014-01-21
Recalling firm: GE Healthcare
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.).
Product code: KPS System, Tomography, Computed, Emission
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
FDA root cause: Radiation Control for Health and Safety Act
Action: GE Healthcare will remedy the issue or bring the product into compliance with each applicable Federal standard. GE Healthcare has provided field modification instructions (FMI) to update software for the Discovery NM/CT570c hybrid system. The software update will correct the incorrect positioning of the table not prescribed by the operator. The FMI includes: A software upgrade with foreign language support to be installed in the affected models listed above, Labels (FMI label and packing label), Software upgrade workflow procedure with functional verification for all modes of operation, and Certification Report, Postponement of Medical Device Correction, Rejection of Medical Device Correction, or Refusal and/or Location Unknown Documentation. For further questions please call (262) 513-4122.
Quantity in commerce: 10 Systems
Distribution: US Distribution in the state of CT.
Product codes and lots: Part numbers H3000SA UFC Cardiac SPECT System, H3001JA UFC Gantry, H3001JE UFC VCT Connecting Kit, H3001JF DISCOVERY NMV/CT 570C Connecting Kit.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1967-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1967-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-20

Product code KPS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)