Centricity PACS-IW with Universal Viewer — Class II medical device recall Z-0139-2024
Ongoing recall by GE Healthcare, reported 2023-11-01. GE HealthCare has become aware of an issue where images from two different patients may be contained in a sing
| Recall number | Z-0139-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, Chicago, IL, United States |
| Recall initiated | 2023-09-14 |
| Classified | 2023-10-20 |
| Reported by FDA | 2023-11-01 |
| Countries outside the US | AT, BR, CA, CH, CL, CO, DE, ES, FR, GB, IE, IN, IT, KW, MY, NL, PA, PL, RU, SA, SI, UY, VE, VN, ZA |
| Quantity | 17 units |
Product
Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation; Radiological Image Processing System
Reason for recall
GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x, Centricity PACS-IW with Universal Viewer V5.0 and Centricity Universal Viewer V6.0 with PACS-IW foundation.
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-0139-2024. 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.