Recall Z-3146-2024 ยท LLZ System, Image Processing, Radiological
GE Healthcare GmbH
ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD, h) H47591YA; system, imaging processing, radiological
| Date | Sep 13, 2024 (initiated Aug 8, 2024) |
| Status | Open, Classified |
| 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. |
| 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 secur |
| Quantity | 574 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103458 | VIEWPOINT 6 GE Healthcare, Mar 4, 2011 |
| K162743 | ViewPoint 6 GE Medical Systems Ultrasound and Primary Care Diagnostics, Nov 22, 2016 |
| K173456 | ViewPoint 6 Ge Medical Systems Ultrasound and Primary, Jan 5, 2018 |
| K192917 | ViewPoint 6 Ge Medical Systems Ultrasound And, Jan 6, 2020 |
| K203677 | ViewPoint 6 GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC, Jan 15, 2021 |
| K241300 | ViewPoint 6 Ge Healthcare GmbH, Jul 2, 2024 |