Recall Z-3145-2024— GE Healthcare GmbH

Name: FDA recall Z-3145-2024
Creator: U.S. Food and Drug Administration
Published: 2024-08-08

Class II · Ongoing

Class II FDA medical device recall by GE Healthcare GmbH, initiated 2024-08-08. It names one FDA 510(k) clearance: K050943. Product: ViewPoint; system, imaging processing, radiological. Reason: 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..

Recalling firm: GE Healthcare GmbH
Classification: Class II
Status: Ongoing
Initiated: 2024-08-08
Firm location: Munich, Germany

510(k) clearances named in this recall

1 on FDA's record

K050943 — GE VIEWPOINTGeneral Electric Co.·cleared 2005-05-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.