Recall Z-3146-2024— GE Healthcare GmbH

Name: FDA recall Z-3146-2024
Creator: U.S. Food and Drug Administration
Published: 2024-08-08

Class II · Ongoing

Class II FDA medical device recall by GE Healthcare GmbH, initiated 2024-08-08. It names 6 FDA 510(k) clearances: K241300, K203677, K192917 and 3 more. 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..

Recalling firm: GE Healthcare GmbH
Classification: Class II
Status: Ongoing
Initiated: 2024-08-08
Firm location: Munich, Germany

510(k) clearances named in this recall

6 on FDA's record

K241300 — ViewPoint 6Ge Healthcare GmbH·cleared 2024-07-02
K203677 — ViewPoint 6GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC·cleared 2021-01-15
K192917 — ViewPoint 6Ge Medical Systems Ultrasound And·cleared 2020-01-06
K173456 — ViewPoint 6Ge Medical Systems Ultrasound and Primary·cleared 2018-01-05
K162743 — ViewPoint 6GE Medical Systems Ultrasound and Primary Care Diagnostics·cleared 2016-11-22
K103458 — VIEWPOINT 6GE Healthcare·cleared 2011-03-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.