Recall Z-1749-2019 ยท KPS System, Tomography, Computed, Emission
GE Healthcare, LLC
Discovery Ml Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.
| Date | Jun 19, 2019 (initiated Feb 12, 2019) |
| Status | Open, Classified |
| Reason | GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure |
| Root cause | Radiation Control for Health and Safety Act |
| Action | GE Healthcare sent a notification letter to affected customer (Hospital Administrators/Risk Managers. Managers of Radiology/Cardiology, Radiologist/Cardiologist). The letter identified the affected product, problem and actions to be taken. Customers were informed GE Healthcare will without charge, remedy the defect or bring the product into compliance. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. |
| Quantity | 1113 in total |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161574 | Discovery MI Ge Medical Systems, LLC, Aug 11, 2016 |