ViewPoint 6 — Class II medical device recall Z-3146-2024
Ongoing recall by GE Healthcare GmbH, reported 2024-09-25, distributed nationwide. The National Institute of Standards and Technology (NIST) has identified in the National Vulnerability Databas
| Recall number | Z-3146-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare GmbH, Munich, Germany |
| Recall initiated | 2024-08-08 |
| Classified | 2024-09-13 |
| Reported by FDA | 2024-09-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | MX |
| Quantity | 574 units |
| UPC / GTIN / UDI-DI | 00195278517340, 00840682103640, 00840682119627, 00840682124454, 00840682140744, 00840682145718, 00840682171953 |
Product
ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD, h) H47591YA; system, imaging processing, radiological
Reason for recall
The National Institute of Standards and Technology (NIST) has identified in the National Vulnerability Database (NVD) that NexGen Healthcare Mirth Connect, prior to version 4.4.1, has a potential vulnerability allowing the deserialization of untrusted data (CVE-2023-43208). Mirth products may have been installed and configured with your ViewPoint / ViewPoint 6 system by GE HealthCare. This vulnerability could allow a malicious actor 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-3146-2024. 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.