Recall – Software error results in incorrect scanning location

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, Waukesha, WI on 7/12/2018. FDA Mandated

VOLUME OF PRODUCT IN COMMERCE
131 units

DISTRIBUTION
U.S. Nationwide and International

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