Tag: class_ii_recall

FDA Classifies GE HealthCare Monitoring Software Issue as Class II Recall

3 Sep 2026 1:28 p.m. · Source: US Food and Drug Administration

The FDA has reclassified an early alert for GE HealthCare's Portrait Core Services Software as a Class II Recall. The issue, identified during a service update, has not led to patient monitoring disruptions.

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