NM/CT 860 Nuclear Medicine / CT Scanners
Check against the official notice below — it lists the full affected range.
GE Healthcare has recalled 242 NM/CT 800 family scanners worldwide (17 units in the US) due to a potential issue that could shift the CT radiation exposure range by up to 5 centimeters from the intended exposure range during planned scans. The problem occurs only when using a hybrid whole-body continuous F3 protocol with Zoom less than 1 where the scan range is set on the Smart Console. In some cases, this misalignment may require patients to undergo repeat scans, resulting in additional X-ray radiation exposure.
The recall record does not specify a remedy or any steps for affected consumers to 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*00840682140751
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.