ViewPoint; system, imaging processing, radiological
This recall is currently active, issued September 13, 2024. It was issued by Ge Healthcare Gmbh Oskar-Schlemmer-Str. 11 Munich Germany.
- Recall Initiated
- August 8, 2024
- Posted
- September 13, 2024
- Recall Number
- Z-3145-2024
- Quantity
- 3 units
- Official Source
- View on FDA website ↗
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.
Distribution
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.
Lot / Code Info
No UDI/DI, System ID numbers: QB7A TA99, N26D M0B7, Q1K1 FFQW
Root Cause
Device Design
Action Taken
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.