PV Bulletin

Monitoring System Correction: GE HealthCare Updates Use Instructions for Portrait Core Services Software

GE HealthCare has updated the use instructions for the Portrait Mobile monitoring system due to potential discharges of patients from monitoring during software updates.

Primary source: What is an Early Alert?

PV Impact Brief

Urgency: HighConfidence: high

What changed

The FDA clarified the reason for the recall and communicated that it is classified as a Class II Recall regarding the use of GE HealthCare's Portrait Core Services software. This includes providing updated use instructions for ensuring patient monitoring safety.

Why it matters

Failure to follow the updated use instructions may lead to a loss of patient monitoring capability or incorrect alarm notifications, which could potentially result in reversibly harmful health outcomes.

Action needed

Facilities must ensure that appropriate alternative monitoring is established for patients before performing software updates and include the User Manual addendum with the equipment.

Relevant for
Labeling LeadRegulatory Intelligence Lead
Processes impacted
LabelingSignal Management
Owner

Regulatory Intelligence Lead

Review cadence

Review in the next regulatory intelligence cycle.

Evidence and confidence

Confidence: highSource updated: Sep 3, 2026

Full briefing

Practical implication

Facilities must ensure that appropriate alternative monitoring is established for patients before performing software updates and include the User Manual addendum with the equipment.

The FDA has classified the issue as a Class II Recall after determining that the Portrait Core Services software updates could lead to patient discharges from monitoring and incorrect alarm settings. Facilities must implement alternative monitoring methods prior to updates.

What changed: The FDA clarified the reason for the recall and communicated that it is classified as a Class II Recall regarding the use of GE HealthCare's Portrait Core Services software. This includes providing updated use instructions for ensuring patient monitoring safety.

Why it matters: Failure to follow the updated use instructions may lead to a loss of patient monitoring capability or incorrect alarm notifications, which could potentially result in reversibly harmful health outcomes.

Practical implication: Facilities must ensure that appropriate alternative monitoring is established for patients before performing software updates and include the User Manual addendum with the equipment.

View original source

  • Source: FDA - MedWatch Safety Alerts RSS
  • Published at source: 2026-09-03T00:00:00.000Z
  • Discovered by monitor: 2026-09-03T21:47:54.027Z

Published from the regulator source ingestion pipeline after PV impact triage.

#Labeling#Safety Signals#Source-ingestion#Regulator-monitor#Usa#Fda.gov

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