FDA Device recall Z-0143-2024
Universal Viewer Workflow Manager, Image processing radiological system
- FDA Device
- Class II
- ongoing
- Published 2023-11-01
On 2023-11-01 the FDA classified a Class II recall of Universal Viewer Workflow Manager, Image processing radiological system by Ge Healthcare, citing when using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a third-party reporting application is used to launch exams, it could display informatio….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0143-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-09-08 |
| Published | 2023-11-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
Universal Viewer Workflow Manager, Image processing radiological system
Reason
When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a third-party reporting application is used to launch exams, it could display information on a different patient than WFM and the Viewer.
Identifiers
| code_info | UDI/DI 00195278379610, Software versions 7.0 SP1.1, 7.0 SP1, 7.0 SP0.0.5, 7.0 SP0.1.0. All product IDs with an affected software version are impacted. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0143-2024%22
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