The FDA posted a Class II correction on September 3 for GE HealthCare's Portrait Core Services software. During a software update, patients monitored on Portrait Mobile devices could be discharged from the monitoring system. Alarm settings could also reset to factory defaults, so the device would stop following the settings a clinician had configured.
Affected versions are Portrait Core Services V1.0.5 and V1.1, Portrait Compute and Core Services V1.2, and the field replaceable V1.1 reload. GE HealthCare had reported no serious injuries or deaths as of July 29. The agency issued an early alert on the same issue on August 21.
GE told customers to keep using the monitors, to arrange alternative monitoring before starting any update, and to post a user manual addendum next to the existing manuals.
Update behavior is a design control item, not an IT chore. If your device can lose a patient session or revert a configured alarm during a field update, that belongs in the risk file and in the human factors work. A line in the manual is not a mitigation.