FDA (Devices) recall action 87811
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
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.
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.
The agency’s own wording, quoted from the enforcement report.
GE Healthcare is recalling NM/CT 870 DR scanners because a specific workflow may cause a shift in CT radiation exposure range, potentially requiring patient re-scans.
GE Healthcare is recalling NM/CT 850 scanners because a specific workflow may cause a 5cm shift in CT radiation exposure, potentially requiring patient re-scans.
GE Healthcare is recalling NM/CT 860 scanners because a specific protocol may cause a 5cm shift in radiation exposure, potentially requiring patient re-scans.