Recall Z-0793-2019— GE Healthcare, LLC

Name: FDA recall Z-0793-2019
Creator: U.S. Food and Drug Administration
Published: 2018-12-20

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2018-12-20, terminated 2021-04-09. It names one FDA 510(k) clearance: K150420. 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.. 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: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2018-12-20
Terminated: 2021-04-09
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K150420 — Centricity Universal ViewerGE Healthcare·cleared 2015-05-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.