GE Healthcare, LLC: Medical Device Recall in 2021 - (Recall #: Z-0012-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system

Product Classification:

Class II

Date Initiated: August 12, 2021

Date Posted: October 13, 2021

Recall Number: Z-0012-2022

Event ID: 88595

Reason for Recall:

A software anomaly exists in the Centricity Universal Viewer study management feature in which study changes are not propagated to either the Centricity Enterprise Archive (EA) or another Vendor Neutral Archive (VNA).

Status: Terminated

Product Quantity: 49

Code Information:

Centricity Universal Viewer, Software Versions 7.0 SP0.0.4.5 and 7.0 SP0.0.5 GTIN 00840682145794

Distribution Pattern:

AR, IL, ME, MS, NE, NJ, NY, and TN Belgium, Canada, Costa Rica, France, Germany, India, Japan, Korea, Kuwait, Saudi Arabia, Singapore, Switzerland, Switzerland, Turkey and United Kingdom

Voluntary or Mandated:

Voluntary: Firm initiated