Z-3145-2024 Class II Ongoing

Recalled by GE Healthcare GmbH — Munich

Recall Details

Product Type
Devices
Report Date
September 25, 2024
Initiation Date
August 8, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3 units

Product Description

ViewPoint; 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.

Distribution Pattern

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.

Code Information

No UDI/DI, System ID numbers: QB7A TA99, N26D M0B7, Q1K1 FFQW