FDA-Device2021-05-19Class II
NM/CT 870 DR Nuclear Medicine / CT Scanners
GE Healthcare, LLC
Hazard
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.
Sold states
Worldwide distribution - US Nationwide
Affected count
242 in total (17 units US)
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
NM/CT 870 DR Nuclear Medicine / CT Scanners
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1547-2021Don't want to check this manually?
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