Beta Bionics, Inc.: Alternate Controller Enabled Insulin Infusion Pump

insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring (CGM) G7 sensor may result in delayed CGM reading then switch to non-CGM dosing, leading to only basal/requested meal doses provided, no correction doses/insulin reductions/suspensions for high/low glucose unless blood glucose entered for sensor life or replacement. Potential health risks to users include severe hyperglycemia with and without DKA and severe hypoglycemia.

Tags

FDA recall, medical device, class 2, Clinical Chemistry, Software change control, Open, Classified

Related exam domains

CISSP 3: Security Architecture and Engineering; CISSP 4: Communication and Network Security; CISSP 7: Security Operations; CISM 3: Information Security Program

Source record id

Z-1996-2026

First seen by InfoSec Signals

9/23/2026

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