FDA Device recall Z-3146-2024
ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD, h) H47591YA
- FDA Device
- Class II
- ongoing
- Published 2024-09-25
On 2024-09-25 the FDA classified a Class II recall of ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD, h) H47591YA by Ge Healthcare, citing 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,….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3146-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-08-08 |
| Published | 2024-09-25 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ge Healthcare |
| Distribution | US |
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
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.
Identifiers
| code_info | a) H47581RJ: UDI/DI none, System ID Numbers: 4AD8 4XH3, JC82 KQTA, JZNQ HCW6, 8X0C HWWG, NURM T75T, 7R98 NQWY, AS41 Z…a) H47581RJ: UDI/DI none, System ID Numbers: 4AD8 4XH3, JC82 KQTA, JZNQ HCW6, 8X0C HWWG, NURM T75T, 7R98 NQWY, AS41 ZJKE, ZU21 YYU8, E09H GGMN, DZMC NUA6, CYPQ ARE7, HJDP BKTB, TMQA Y5KK; b) H47591MA: UDI/DI (01)00840682103640(10)SP1, System ID Numbers: ND1G 9XAQ, Q6BJ 97G9, N8XB JU3W, UD55 W4Y3, KN5N NE40, TPF5 XNX3, 3WUB CTJ7, 113A SQPB, ZPFQ PU2B, MCH1 D8NX, Y9EP 31QZ, and UDI/DI (01)00840682103640(10)SP2, System ID Numbers: 20GN P6K5, NZHH 8S6X, F7RD DEWF, BJ4S RHT3, M6CS 194S, 0EKT TEUF, 4M7U QK91, RH1J 5CQ4; c) H47591MT: UDI/DI (01)00840682119627(10)ViewPoint6ver6.8SP1, System ID Numbers: A9PQ QW8P, HQDC YM8P, QQA4 5NMB, BGWN FEDE, QWMX 3H8H, BWXS F2FH, CZE2 JKSD, BB1Z NZ0R, N5MC 865W, ZUUT 01QZ, 6XX2 SW1N, 4F2C Y3PQ; d) H47591PE: UDI/DI (01)00840682124454(10)ViewPoint6ver6.9SP1, System ID Numbers: G00B ZJM0, 3EU2 009D, 0XP7 EJ8B, 2RUA PEXN, XNG8 X0DD, T0B8 YRFY, WGC2 8WNW, XTZN HZZZ, RJ0X 800T, BEJF WA1P, ZWM3 FRS9, 2WS7 2E10, 36SG U594, H1KX 82WQ, B8RY Z8EX, 7H6Q RE0 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3146-2024%22
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