Z-3145-2024Class II

ViewPoint; system, imaging processing, radiological

Name: Z-3145-2024 ViewPoint; system, imaging processing, radiological
Creator: GE Healthcare GmbH
Published: 2024-08-08
License: https://open.fda.gov/license/

GE Healthcare / initiated 2024-08-08 / Open, Classified / root cause: design

FDA source

GE Healthcare GmbH began a recall of ViewPoint; system, imaging processing, radiological on 2024-08-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-3145-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-08
Posted: 2024-09-13
Recalling firm: GE Healthcare
Product: ViewPoint; system, imaging processing, radiological
Product code: LLZ System, Image 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.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 3 units
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.
Product codes and lots: No UDI/DI, System ID numbers: QB7A TA99, N26D M0B7, Q1K1 FFQW

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3145-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3145-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-25	2024-09-13
Z-3146-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-25	2024-09-13

Product code LLZ

K050943Class IIGe ViewpointGeneral Electric Co. / cleared 2005-05-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)