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
- Recall Number
- Z-3146-2024
- Event Number
- 95167
- Firm
- GE Healthcare GmbH Oskar-Schlemmer-Str. 11 Munich Germany
- FEI Number
- 3004497354
- Product Code
- LLZ
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- August 8, 2024
- Posted
- September 13, 2024
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
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.
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.
US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin.
574 units