Tag: ge_healthcare

• 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.

  HealthScience & TechnologyPolitics and GovernmentMedical ScienceComputers and InternetFederal GovernmentLegal GE HealthCareFDAPortrait Core Services SoftwareMedical DeviceProduct RecallClass II RecallPatient MonitoringFood RecallsDrugs

• FDA Issues Early Alert for GE HealthCare Software Issue

  21 Aug 2026 4:07 p.m. · Source: US Food and Drug Administration

  The FDA has issued an Early Alert regarding GE HealthCare's Portrait Core Services software. An update issue may cause patient discharge from monitoring and reset alarm settings, potentially leading to loss of monitoring or alarms. No serious injuries or deaths…

  HealthScience & TechnologyBusinessMedical ScienceComputers and InternetFederal Government FDAGE HealthCarePortrait Core ServicesMedical DeviceSoftware IssuePatient MonitoringEarly AlertFood RecallsDrugs

• FDA Issues Early Alert for GE HealthCare Infant Resuscitation Systems Over Oxygen Delivery Risk

  5 Jun 2026 2:50 p.m. · Source: US Food and Drug Administration

  The FDA has issued an Early Alert for GE HealthCare Infant Resuscitation Systems due to loose blender knob shafts. This defect could cause incorrect oxygen delivery, posing risks of hypoxia or hyperoxia to infants, though no serious injuries are reported.

  HealthBusinessPolitics and GovernmentMedical ScienceFederal GovernmentLegalSocial Issues GE HealthCareInfant Resuscitation SystemsFDAMedical DevicesOxygen ConcentrationProduct RecallPatient SafetyFood RecallsDrugs

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