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 | Centricity Universal Viewer measurements saved into a DICOM Grayscale Presentation State are incorrect in subsequent views for exams containing series with different pixel sizes and may lead to a potential misdiagnosis. |
| Product | Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources, and from other healthcare information sources. |
| Quantity | 205 |
| Distribution | Distributed nationwide; Internationally distributed to Mexico and 24 additional countries. |
| Initiated | 2019-12-16 |
| Classified | 2020-01-17 |
| Terminated | 2023-10-05 |
| Recall number | Z-0819-2020 |
| 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-0819-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84584/
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