Day

April 29, 2026
29
Apr

FDA Recall: Software error may result in delayed GCM reading

April 29, 2026
Company: Beta Bionics, Inc. Date of Enforcement Report: 4/29/2026 Class: II PRODUCT: iLet Bionic Pancreas, REF: BB1001 Recall Number: Z-1996-2026 REASON: 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,...
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