Discovery PET/CT 610 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.
Recall
- Recall Number
- Z-1745-2019
- Event Number
- 82982
- Firm
- GE Healthcare, LLC
- FEI Number
- 2126677
- Product Code
- KPS
- Status
- Open, Classified
- Root Cause
- Radiation Control for Health and Safety Act
- Initiated
- February 12, 2019
- Posted
- June 19, 2019
- Address
- 3000 N Grandview Blvd, Waukesha, WI, 53188-1615
Description
Discovery PET/CT 610 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.
GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure
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.
Nationwide Distribution
1113 in total