Company: GE Healthcare, LLC
Date of Enforcement Report: 2/6/2019
Class II:
PRODUCT
Revolution CT systems with the SmartStep Option The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
Recall Number: Z-0776-2019
REASON
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
RECALLING FIRM/MANUFACTURER
GE Healthcare, LLC on 7/12/2018. FDA Mandated.
VOLUME OF PRODUCT IN COMMERCE
131 units
DISTRIBUTION
US Nationwide and International