Class II — GE Healthcare, LLC
| Recalling firm | GE HealthCare Technologies Inc. |
|---|---|
| Registered facility | View this company's 50 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Remote comparison studies displayed may be associated with the wrong patient, without a caution icon present. |
| Product | Centricity Universal Viewer with Cross Enterprise Display This impacts product versions 6.0 SP1 and higher. |
| Quantity | 1 |
| Distribution | NY |
| Initiated | 2018-08-30 |
| Classified | 2018-10-18 |
| Terminated | 2022-08-31 |
| Recall number | Z-0195-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — GE Healthcare, LLC (Z-0195-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81297/
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