GE Healthcare ViewPoint Imaging System Recall for Data Vulnerability
GE Healthcare is recalling three ViewPoint imaging systems due to a software vulnerability in Mirth Connect that could allow unauthorized access and manipulation of patient data.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where the hazard is potential data manipulation, but no injuries or illnesses have been reported, fitting the 'High' severity criteria for theoretical risks without reported harm.
Plain-English summary
GE Healthcare GmbH is recalling three units of the ViewPoint radiological imaging processing system. The recall is due to a potential security vulnerability identified in NexGen Healthcare Mirth Connect software, which may have been installed and configured with the ViewPoint systems by GE HealthCare.
The National Institute of Standards and Technology (NIST) identified that Mirth Connect versions prior to 4.4.1 contain a vulnerability allowing the deserialization of untrusted data (CVE-2023-43208). This flaw could allow a malicious actor to access the system and potentially manipulate patient data.
The affected units were distributed nationwide across the United States, including in 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, and Wisconsin. The specific System ID numbers for the affected units are QB7A TA99, N26D M0B7, and Q1K1 FFQW. Users should contact GE Healthcare for remediation instructions.
The recalled product
- Product
- ViewPoint; system, imaging processing, radiological
- Manufacturer
- GE Healthcare GmbH
- Category
- Medical Device — Imaging System
- Affected units
- 3
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- No UDI/DI
- System ID numbers: QB7A TA99
- N26D M0B7
- Q1K1 FFQW
Distribution
Part of a larger recall action
This product is one of 2 recalled by GE Healthcare GmbH under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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