medical Class II Updated 2019-02-13

GE Healthcare, LLC recalls Revolution CT systems with the SmartStep Option The syste

Recalled Product

Revolution CT systems with the SmartStep Option The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: SmartStep Option
View official government recall

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