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FDA Reports Injuries in GE HealthCare Portrait Monitoring Software Alert

The FDA has received reports of injuries linked to a software issue in GE HealthCare's Portrait monitoring system, according to Medical Daily.

3 reports on this incident · first at Aug 25, 2026, 10:54 p.m. ET

By AI ReporterFirst reported Aug 25, 2026, 10:40 p.m. ETWritten Aug 25, 2026, 11:05 p.m. ET
The U.S. Food and Drug Administration (FDA) has reported injuries associated with a software issue in 's Portrait Mobile Monitoring Solution, according to Medical Daily. The agency's , which remains , states that during a software update, some patients were discharged from the monitoring system and alarm settings may reset to factory defaults, potentially leading to loss of patient monitoring or intended alarms at the Hub and Central Viewer. , but the FDA has now received reports of injuries, as stated by Medical Daily. The affected products include Portrait Core Services Software versions 1.0.5 and 1.1, Portrait Compute and Core Services version 1.2, and a field-replaceable software reload for version 1.1. The FDA advises hospitals to ensure appropriate alternative monitoring is in place for patients before any software update begins. The cause of the issue has not been determined, and the alert is .

Earlier reports

  1. Aug 25, 2026, 10:59 p.m. ET

    FDA Closes Early Alert on GE HealthCare Portrait Monitoring Software

    The U.S. Food and Drug Administration has closed its early alert on GE HealthCare's Portrait Mobile Monitoring Solution, according to Medical Daily. The agency considers the recall carried out, meaning the action is complete.

    The alert, issued earlier, covered Portrait Core Services Software versions 1.0.5 and 1.1, Portrait Compute and Core Services version 1.2, and a field-replaceable software reload for version 1.1. The hazard was loss of patient monitoring or of the intended alarms at the Hub and Central Viewer during a software update, which could also reset alarm settings to factory defaults.

    GE HealthCare had not reported any serious injuries or deaths associated with the issue, Medical Daily reported. The remedy advised hospitals to ensure appropriate alternative monitoring is in place for patients before any software update begins.

  2. Aug 25, 2026, 10:54 p.m. ETFirst report

    FDA Issues Early Alert on GE HealthCare Portrait Monitoring Software

    The U.S. Food and Drug Administration (FDA) has issued an early alert regarding certain GE HealthCare Portrait monitoring software, according to a report by Medical Daily. The alert covers Portrait Mobile, Portrait Core Services, and Portrait Compute and Core Services, and was reported on August 26, 2026.

    The issue involves a potential loss of patient monitoring or of the intended alarms at the Hub and Central Viewer during a software update. The FDA's early alert states that during a software update, some patients may be discharged from the monitoring system, and alarm settings may reset to factory defaults. GE HealthCare had not reported any serious injuries or deaths associated with the issue, according to Medical Daily.

    The affected software versions include Portrait Core Services Software versions 1.0.5 and 1.1, Portrait Compute and Core Services version 1.2, and a field-replaceable software reload for version 1.1. The Portrait Mobile Monitoring Solution acquires, stores, calculates, displays, and exports patient monitoring data, and provides real-time alarming for adult and pediatric patients.

    The FDA's early alert advises hospitals to ensure that appropriate alternative monitoring is in place for patients before any software update begins. The status of the alert is ongoing.

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Revision history

  1. Version 126 Aug 2026, 02:54current

    First published.

  2. Version 126 Aug 2026, 03:05current

    First published.

  3. Version 126 Aug 2026, 03:10

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  4. Version 126 Aug 2026, 02:59current

    First published.

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