GE Healthcare, LLC Recall 88595
Description: Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
GE Healthcare, LLC Recall 88595 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0012-2022 |
| Event ID | 88595 |
| Event Description | Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system |
| Product Type | Devices |
| 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 |
| Quantity | 49 |
| Recall Reason | 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). |
| Device Classification | 20211013 |
| Device Code Info | Centricity Universal Viewer, Software Versions 7.0 SP0.0.4.5 and 7.0 SP0.0.5 GTIN 00840682145794 |
| Center Classification Date | 20211001 |
| Recall Initiation Date | 20210812 |
| Recalling Firm | GE Healthcare, LLC |
| Initial Notification | Letter |
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