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Open, Classified

GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592

FDA Recall Z-2878-2026 · Posted 2026-08-04

Recalling FirmGE Medical Systems Information Technologies Inc
Recall StatusOpen, Classified
Product CodeMWI
Date Initiated2026-07-10
Product Quantity11 units

Reason for Recall

Portrait Core Services Software version V1.2.0 Security Vulnerability

Firm 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 with the security considerations outlined in the GE HealthCare Portrait Mobile Monitoring Solution Privacy and Security Manual p/n 5970026. Please retain this document for your records." For questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or a local Service Representative.

Root Cause

Software design

Distribution Pattern

Worldwide - US Nationwide distribution in the state of MI, and the countries of Czech Republic, Finland, Germany, Netherland, Qatar, UAE.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application (Portrait CVAXB) • Portrait™ Core Services (Portrait CSSXB) • Portrait™ Clinical Alarming Unit (Portrait CAU01) • Portrait™ Mobile Patient Monitor Hardware (Portrait HUBXB) • Portrait™ Mobile Patient Monitor Software (Portrait HSWXB) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) • Portrait™ Wearable Pulse OGe Medical Systems Information Technologies, Inc. · 2024-03-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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