Z-0012-2022 Class II Terminated

Recalled by GE Healthcare, LLC — Waukesha, WI

Recall Details

Product Type
Devices
Report Date
October 13, 2021
Initiation Date
August 12, 2021
Termination Date
August 22, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
49

Product Description

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

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).

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

Code Information

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