GE Healthcare, LLC: Medical Device Recall in 2019 - (Recall #: Z-0793-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: December 20, 2018

Date Posted: February 13, 2019

Recall Number: Z-0793-2019

Event ID: 81975

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.

Status: Terminated

Product Quantity: 297 (131 US; 166 OUS)

Code Information:

Centricity Universal Viewer versions 6.0 SP4 or higher with Breast Imaging integrated with either IDI Mammo Workstation version 4.7.x or any version of SenoIris.

Distribution Pattern:

Worldwide Distribution: US (nationwide) in states of: AZ, CA, CO, DE, FL, IA, IL, IN, KS, MA, ME, MI, MN, MO, MS, MT, NE, NJ, NV, NY, OH, PA, PR, SC, SD, TN, TX, VA, VT, and WI; and countries of: Antigua, Australia, Austria, Belgium, Bermuda, Brazil, Canada, Cayman Islands, Chile, Colombia, Cote d'Ivoire, France, Germany, Guatemala, India, Italy, Korea, Kuwait, Lebanon, Malaysia, Malta, Mexico, Panama, Russia, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Turkey, United Arab Emirates, United Kingdom, and Venezuela.

Voluntary or Mandated:

Voluntary: Firm initiated