The U.S. Food and Drug Administration (FDA) has issued an Early Alert concerning GE HealthCare's Portrait Core Services software, advising customers about updated use instructions for Portrait Mobile Monitoring Solutions. This alert follows an issue identified during a software update.
GE HealthCare reported that during an update of the Portrait Core Services software, some patients monitored on Portrait Mobile devices were discharged from the system. Additionally, all alarm settings may reset to factory defaults, potentially leading to a loss of patient monitoring or intended alarms at the Hub and Central Viewer.
As of July 29, GE HealthCare has not reported any serious injuries or deaths associated with this issue. The FDA's Center for Devices and Radiological Health (CDRH) said it is issuing this "Early Alert" to inform the public of a potentially high-risk device issue. The FDA will provide updates as significant new information becomes available.