GE Healthcare GmbH: Device Recall

Recall #Z-0935-2026 · 11/03/2025

Class II: Risk

Recall Details

Recall Number: Z-0935-2026
Classification: Class II
Product Type: Device
Recalling Firm: GE Healthcare GmbH
Status: Ongoing
Date Initiated: 11/03/2025
Location: Munich, Germany
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1221 units

Reason for Recall

GE HealthCare has become aware that the Patient History tab in ViewPoint 6 versions 6.15.3 and 6.15.4 ultrasound software may not include complete patient medical history information.

Product Description

GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system

Distribution Pattern

Worldwide

Other Recalls by GE Healthcare GmbH

Class II: Risk 08/08/2024

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.
Class II: Risk 08/08/2024

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.

View all recalls by GE Healthcare GmbH →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.