FDA Expands Class II Recall of GE HealthCare Portrait Monitoring Software
The recall now covers additional versions of Portrait Core Services and the Portrait Compute and Core Services package.
5 reports on this incident · first at Sep 4, 2026, 11:57 a.m. ET
Earlier reports
Sep 4, 2026, 12:12 p.m. ET
FDA Classifies GE HealthCare Portrait Monitoring Recall as Class II
The U.S. Food and Drug Administration (FDA) has classified GE HealthCare's recall of certain Portrait monitoring software as Class II, according to a report from Medical Daily. The classification applies to Portrait Core Services versions 1.0.5 and 1.1, the Portrait Compute and Core Services package at version 1.2, and a software reload component. The agency's action is ongoing.
The recall was prompted by a hazard that some monitored patients can be removed from the Portrait system and alarm settings can reset to factory defaults, which could lead to a loss of patient monitoring or of the intended alarms at the hub and central viewer. The Portrait Mobile Monitoring Solution is designed to acquire, store, calculate, display, and export patient monitoring data and to provide real-time alarms for adult and pediatric patients.
As of July 29, GE HealthCare had not reported any serious injuries or deaths associated with the issue, Medical Daily reported.
Sep 4, 2026, 12:07 p.m. ET
FDA Reports Injuries in Ongoing GE HealthCare Portrait Monitoring Recall
The U.S. Food and Drug Administration (FDA) has received reports of injuries associated with the ongoing recall of GE HealthCare's Portrait monitoring software, according to Medical Daily. The agency has classified the recall as Class II. As of July 29, GE HealthCare had not reported any serious injuries or deaths associated with the issue, Medical Daily reported.
The recall affects Portrait Core Services versions 1.0.5 and 1.1, the Portrait Compute and Core Services package at version 1.2, and a software reload component. The products are marketed under the brand names Portrait Core Services, Portrait Mobile, and Portrait Compute and Core Services. The Portrait Mobile Monitoring Solution is designed to acquire, store, calculate, display, and export patient monitoring data and to provide real-time alarms for adult and pediatric patients.
The FDA said the issue can cause some monitored patients to be removed from the Portrait system and alarm settings to reset to factory defaults, potentially leading to loss of patient monitoring or of the intended alarms at the hub and central viewer. The recall status is ongoing.
Sep 4, 2026, 12:01 p.m. ET
FDA Closes Class II Recall of GE HealthCare Portrait Monitoring Software
The U.S. Food and Drug Administration has closed the recall action for GE HealthCare's Portrait Mobile Monitoring Solution software, according to a report from Medical Daily. The agency considers the recall carried out.
The recall, classified as Class II, affects Portrait Core Services versions 1.0.5 and 1.1, the Portrait Compute and Core Services package at version 1.2, and a software reload component. The action was taken because some monitored patients can be removed from the Portrait system and alarm settings can reset to factory defaults, which could lead to loss of patient monitoring or of the intended alarms at the hub and central viewer.
GE HealthCare had not reported any serious injuries or deaths associated with the issue as of July 29, according to Medical Daily. The Portrait Mobile Monitoring Solution is designed to acquire, store, calculate, display, and export patient monitoring data and to provide real-time alarms for adult and pediatric patients.
Sep 4, 2026, 11:57 a.m. ETFirst report
FDA Classifies GE HealthCare Portrait Monitoring Recall as Class II
The U.S. Food and Drug Administration has classified a recall by GE HealthCare involving certain Portrait monitoring software as Class II, according to a report by Medical Daily. The recall affects the following identifying codes:
- Portrait Core Services versions 1.0.5 and 1.1
- Portrait Compute and Core Services package at version 1.2
- Software reload component
These are associated with the brand names Portrait Core Services, Portrait Mobile, and Portrait Compute and Core Services.
The issue can cause some monitored patients to be removed from the Portrait system and alarm settings to reset to factory defaults, potentially leading to loss of patient monitoring or of intended alarms at the hub and central viewer. The Portrait Mobile Monitoring Solution is designed to acquire, store, calculate, display, and export patient monitoring data and to provide real-time alarms for adult and pediatric patients.
As of July 29, GE HealthCare had not reported any serious injuries or deaths associated with the issue, Medical Daily reported. The recall status is ongoing.
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