Z-0012-2022 Class II Terminated
FDA device recall Z-0012-2022 was initiated by GE Healthcare, LLC on August 12, 2021 and is designated Class II. 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 Neutr… The recall status is terminated (terminated August 22, 2024). Affected quantity: 49.
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