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

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.