GE Healthcare GmbH Oskar-Schlemmer-Str. 11 Munich Germany ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD, h) H47591YA; system, imaging processing, radiological Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice on 08/08/2024 via US Mail. The notice explained the issue, potential risk, and requested the following: You can continue to use your device by following the instructions below: 1.Ensure ViewPoint / ViewPoint 6 is operating in a secure hospital Network such that: a. only authorized personnel have access, b. protections against denial of service and wiretapping/network sniffing are installed by the network operators, and c. access from the Internet is limited where possible 2.Ensure ViewPoint / ViewPoint 6 is operating in a secure Windows environment including confirmation that all relevant software is up to date and operating systems updates are installed. Please ensure all potential users in your facility are made aware of this safety notification.