Device product
NM/CT 860 Nuclear Medicine / CT Scanners
Z-1546-2021
Product summary
- Event
- Event 87811
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 242 in total (17 units US)
- Official record key
device-enforcement:Z-1546-2021
Official wording
Reason: GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could cause a shift in CT radiation exposure range of up to 5cm compared to the intended radiation exposure range of the planned scan under specific workflows. The issue occurs only on a hybrid whole-body continuous F3 protocol with Zoom < 1 where the scan range is set on the Smart Console. In some cases, this may also necessitate a re-scan of the patient, which would expose the patient to additional X-ray radiation.
Code information: GTIN*00840682140751
Distribution pattern: Worldwide distribution - US Nationwide
Derived failure modes
-
Unknown
GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could cause a shift in CT radiation exposure range of up to 5cm compared to the intended radiation exposure range of the planned scan under specific workflows. The issue occurs only on a hybrid whole-body continuous F3 protocol with Zoom < 1 where the scan range is set on the Smart Console. In some cases, this may also necessitate a re-scan of the patient, which would expose the patient to additional X-ray radiation.