Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
This recall has been terminated (originally issued October 2, 2021).
- Company
- Ge Healthcare, Llc
- Recall Initiated
- August 12, 2021
- Posted
- October 2, 2021
- Terminated
- August 22, 2024
- Recall Number
- Z-0012-2022
- Quantity
- 49
- Firm Location
- Waukesha, WI
- Official Source
- View on FDA website ↗
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
Lot / Code Info
Centricity Universal Viewer, Software Versions 7.0 SP0.0.4.5 and 7.0 SP0.0.5 GTIN 00840682145794
Root Cause
Other
Action Taken
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.