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

Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

Corporate Office

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