Recall Z-1967-2013 ยท KPS System, Tomography, Computed, Emission
GE Healthcare, LLC
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
| Date | Aug 20, 2013 (initiated Apr 10, 2013) |
| Status | Terminated |
| 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 |
| 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 |
| Quantity | 10 Systems |
| Distribution | US Distribution in the state of CT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.