GE Healthcare Centricity Radiology RA600 — Class II medical device recall Z-1485-2025
Ongoing recall by GE Healthcare, reported 2025-04-09. There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW),
| Recall number | Z-1485-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, Chicago, IL, United States |
| Recall initiated | 2025-02-19 |
| Classified | 2025-03-28 |
| Reported by FDA | 2025-04-09 |
| Quantity | 1,563 units |
| UPC / GTIN / UDI-DI | 00082499090243, 00082499180098, 00840682125260, 83055000038112 |
| Model numbers | 2022296-001, 2033, 2033901-001, 2038437-00, 2038437-001, 2038437-011, 2038437-012, 2038437-013, 2038437-014, 2038437-0XX, 2098071-004, 2109571-002, 2109571-006, 2109571-010, 2109594-009, 2109594-011, K2090PS, K2090PTED, MANLEGACY114, MANLEGACY64 |
Product
GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 2022296-001; 2) 2033901-001; 3) 2038437-001; 4) 2038437-011; 5) 2038437-012; 6) 2038437-013; 7) 2038437-014; 8) 2038437-0XX; 9) 2098071-004; 10) 2109571-002; 11) 2109571-006; 12) 2109571-010; 13) 2109594-009; 14) 2109594-011; 15) K2090PS; 16) K2090PTED; 17) MANLEGACY114; 18) MANLEGACY64.
Reason for recall
There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.
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-1485-2025. 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.