FDA recall Z-0012-2022

Product

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

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

Key facts

Status

Terminated

Initiation date

2021-08-12

Report date

2021-10-13

Termination date

2024-08-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waukesha, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0012-2022