FDAJuly 12, 2018device
Revolution CT systems with the SmartStep Option The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
On the Revolution CT systems equipped with the SmartStep Option, the Z location displayed on image annotation and on the gantry display may not be the actual location of the table and result in the system scanning at a location that is not what was confirmed by the operator
What to do
FDA enforcement status: Ongoing
Brands named
ge healthcare
Recall history
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