Device product
Optima PET/CT 560, 560FX 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.
Z-1747-2019
Product summary
- Event
- Event 82982
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1113 in total
- Official record key
device-enforcement:Z-1747-2019
Official wording
Reason: GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure
Code information: CT 560, 560FX
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure