NM/CT 850 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 that could shift the CT radiation exposure range by up to 5 centimeters from the intended exposure area during planned scans. The problem occurs specifically when using a hybrid whole-body continuous F3 protocol with Zoom settings below 1 and when the scan range is set on the Smart Console. In some cases, patients may require re-scanning, resulting in additional X-ray radiation exposure. Approximately 242 affected scanners have been distributed worldwide, with 17 units in the United States.
The recall affects equipment with GTIN 00840682140775. The source document does not specify what remedy is available to consumers or facilities affected by this issue.
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*00840682140775
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.