Centricity Universal Viewer 6 — Class II medical device recall Z-0819-2020
Terminated recall by GE Healthcare, LLC, reported 2020-01-29, distributed nationwide. Centricity Universal Viewer measurements saved into a DICOM Grayscale Presentation State are incorrect in subs
| Recall number | Z-0819-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2019-12-16 |
| Classified | 2020-01-17 |
| Reported by FDA | 2020-01-29 |
| Terminated | 2023-10-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | MX |
| Quantity | 205 |
| Model numbers | 2088026-9XX |
Product
Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources, and from other healthcare information sources.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0819-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.