Company: GE Healthcare, LLC
Date of Enforcement Report: 2/1/2019
Class II
PRODUCT
GE Healthcare Centricity Universal Viewer Breast Imaging Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated, stored, and processed. Typical users of this system are authorized healthcare professionals. Centricity Universal Viewer is intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information.
Recall Number: Z-0793-2019
REASON
When switching back & forth between multiple UV instances in the Windows taskbar, the patient images displayed on the mammo high resolution monitors may not show images of the patient selected on UV, which could result in an incorrect diagnosis.
RECALLING FIRM/MANUFACTURER
GE Healthcare, LLC, Waukesha, WI on 12/20/2018. Voluntary: Firm Initiated, recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
297 (131 US; 166 OUS)
DISTRIBUTION
U.S. Nationwide and International