GE Medical Systems, LLC: Medical Device Recall in 2022 - (Recall #: Z-0721-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Centricity PACS-IW with Universal Viewer version 5.0. Used to display medical images (Including mammograms) and data from various imaging sources.

Product Classification:

Class II

Date Initiated: October 28, 2022

Date Posted: December 28, 2022

Recall Number: Z-0721-2023

Event ID: 91159

Reason for Recall:

There is the potential that after installation of the IAS tool, some studies can remain hidden without user notification. Access to those hidden studies requires GE Healthcare assistance, which can result in a delay in reading the study.

Status: Ongoing

Product Quantity: 1 unit

Code Information:

Installed Product ID: YP3150-Centricity Universal Viewer-01639018

Distribution Pattern:

Nationwide distribution to CA, CO, DE, FL, IA, IL, MA, MI, MN, MO, MS, MT, ND, NJ, NY, OK, OR, SD, TX, WI, WV, WY. International distribution to Austria, Brazil, France, Germany, Ghana, Ireland, Italy, Kuwait, Poland, Saudi Arabia, South Africa, Spain, Switzerland, United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated