Discovery PET/CT 710 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.
This recall is currently active, issued June 19, 2019. It was issued by Ge Healthcare, Llc.
- Company
- Ge Healthcare, Llc
- Recall Initiated
- February 12, 2019
- Posted
- June 19, 2019
- Recall Number
- Z-1746-2019
- Quantity
- 1113 in total
- Firm Location
- Waukesha, WI
- Official Source
- View on FDA website ↗
Reason for Recall
GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure
Distribution
Nationwide Distribution
Lot / Code Info
CT 710
Root Cause
Radiation Control for Health and Safety Act
Action Taken
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.