medical Class II Updated 2021-05-19

GE Healthcare, LLC recalls NM/CT 850 Nuclear Medicine / CT Scanners

Recalled Product

NM/CT 850 Nuclear Medicine / CT Scanners

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: GTIN*00840682140775
View official government recall

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