FDA
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Safety-critical software Medical devices
The FDA Says Updates of GE HealthCare's Monitoring Software May Remove Patients From the Monitoring System and Reset Alarm Settings to Factory Defaults
In an early alert of August 21, 2026, updated on September 3, the FDA says GE HealthCare found during a service update at a facility that some monitored patients "may be discharged (removed)" from its Portrait monitoring system, and that all alarm settings may be reset to factory defaults.
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Safety-critical software Medical devices
An FDA Recall Record Says a Defect in Version 7.9 of an Insulin Pump's Software Will Cause It to Incorrectly Interpolate Glucose Trends Under Conditions It Describes
A recall record the FDA posted on April 11, 2025 says a defect in one version of an insulin pump's software "will cause the pump to incorrectly interpolate glucose trends" under conditions it describes, which can lead to under-delivery or over-delivery of insulin.
