NM/CT 870 DR Nuclear Medicine / CT Scanners
Check against the official notice below — it lists the full affected range.
GE Healthcare has identified a potential issue affecting 800 family NM/CT Scanners worldwide, with 17 units in the United States. The problem can cause the CT radiation exposure range to shift up to 5 centimeters from the intended radiation exposure area during specific scanning workflows, particularly when using a hybrid whole-body continuous F3 protocol with Zoom settings below 1 where the scan range is set on the Smart Console. In some cases, this shift may require the patient to undergo an additional scan, resulting in further X-ray radiation exposure.
A total of 242 affected scanners have been distributed globally. The record does not specify a remedy or corrective action that affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Worldwide distribution - US Nationwide Quantity: 242 in total (17 units US) Lot/code info: GTIN*00840682140836
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.