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U.S. Department of Health and Human Services

Class 2 Device Recall ViewPoint

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 Class 2 Device Recall ViewPointsee related information
Date Initiated by FirmAugust 08, 2024
Date PostedSeptember 13, 2024
Recall Status1 Open3, Classified
Recall NumberZ-3145-2024
Recall Event ID 95167
510(K)NumberK050943 
Product Classification System, image processing, radiological - Product Code LLZ
ProductViewPoint; system, imaging processing, radiological
Code Information No UDI/DI, System ID numbers: QB7A TA99, N26D M0B7, Q1K1 FFQW
Recalling Firm/
Manufacturer		 GE Healthcare GmbH
Oskar-Schlemmer-Str. 11
Munich Germany
For Additional Information ContactGE HealthCare Service
800-437-1171
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionGE 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.
Quantity in Commerce3 units
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LLZ
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