Recall Z-2878-2026 · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
GE Medical Systems Information Technologies Inc
GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592
| Date | Aug 4, 2026 (initiated Jul 10, 2026) |
| Status | Open, Classified |
| Reason | Portrait Core Services Software version V1.2.0 Security Vulnerability |
| Root cause | Software design |
| Action | GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION to its consignees on 7/10/2026 via traceable means. The notice explained the safety issue, and requested the following: "Actions to be taken by Customer/User You can continue to use Portrait Mobile Monitoring Solution with Portrait Core Services SW V1.2.0, pending GE HealthCare correction. If you need help to identify if your Portrait Mobile Monitoring Solution has Portrait Core Services SW 1.2.0, contact GE HealthCare Service. Ensure that your facility follows all hospital networking and cybersecurity policies and procedures along |
| Quantity | 11 units |
| Distribution | Worldwide - US Nationwide distribution in the state of MI, and the countries of Czech Republic, Finland, Germany, Netherland, Qatar, UAE. |
| 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 |