FDA Device recall Z-0012-2022
Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
- FDA Device
- Class II
- terminated
- Published 2021-10-13
On 2021-10-13 the FDA classified a Class II recall of Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system by Ge Healthcare, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0012-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-08-12 |
| Published | 2021-10-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ge Healthcare |
| Distribution | AR, IL, ME, MS, NE, NJ, NY, TN |
Product
Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
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).
Identifiers
| code_info | Centricity Universal Viewer, Software Versions 7.0 SP0.0.4.5 and 7.0 SP0.0.5 GTIN 00840682145794 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0012-2022%22
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