GE Healthcare, LLC Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Brand
GE Healthcare, LLC
Lot Codes / Batch Numbers
Centricity Universal Viewer, Software Versions 7.0 SP0.0.4.5 and 7.0 SP0.0.5 GTIN 00840682145794
Products Sold
Centricity Universal Viewer, Software Versions 7.0 SP0.0.4.5 and 7.0 SP0.0.5 GTIN 00840682145794
GE Healthcare, LLC is recalling Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system due to A software anomaly exists in the Centricity Universal Viewer study management feature in which study changes are not propagated to either the Centrici. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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).
Recommended Action
Per FDA guidance
This issue will be resolved by sending an Urgent Medical Device Correction letter to customers with affected software versions on August 13, 2021. This letter informs customers of the issues and provides safety instructions. GE Healthcare will correct the issue through a product change. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AR, IL, ME, MS, NE, NJ, NY, TN
Page updated: Jan 10, 2026