Recall Z-0918-2025 · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
GE Medical Systems, LLC
Portrait Core Services, a set of software services that enable the communication and interaction of the Portrait Mobile Monitoring Solution components and will integrate into existing healthcare facility infrastructure and clinical information systems, Model CSSXB
| Date | Jan 15, 2025 (initiated Dec 6, 2024) |
| Status | Open, Classified |
| Reason | There is a software issue that can result in the loss of patient monitoring on the Portrait Central Viewer Application after 425 days of continuous run-time. |
| Root cause | Software design |
| Action | An URGENT MEDICAL DEVICE CORRECTION notification letter dated 12/6/24 was sent to customers. Actions to be taken by Customer/User: You can continue to use your Portrait" Mobile Monitoring Solution v1.1 product, since all potentially impacted systems were recently installed and the safety issue does not manifest until after 425 days of continuous use. Please follow the annual Maintenance Schedule described in Service Manual (PN 5929144) for your Portrait" Mobile to reboot the system. Rebooting the system by following this procedure resets the continuous days of use to zero. Please complete a |
| Quantity | 7 systems |
| Distribution | Worldwide - US Nationwide distribution in the states of OH, TX and the countries of Australia, China, Czech Republic, France, Italy, Netherlands, Qatar, Singapore, UAE, UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K234130 | Portrait Mobile Monitoring Solution consists of: Portrait Central Viewer Application (Portrait CVAXB) Portrait Ge Medical Systems Information Technologies, Inc., Mar 20, 2024 |