ViewPoint; system, imaging processing, radiological

FDA device recall Z-3145-2024 · posted 2024-09-13 · Open, Classified

Recall details

Recalling firm

GE Healthcare GmbH

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.

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.

Root cause

Device Design

Status

Open, Classified

Product code

LLZ

Quantity affected

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,

Date initiated

2024-08-08

Date posted

2024-09-13

Location

Munich, Germany

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