Day

June 20, 2025
20
Jun

FDA Recall: Software error in diabetes management system may provide a device error and cause the insulin pen to become unresponsive

June 20, 2025
Company: Bigfoot Biomedical Date of Enforcement Report: 6/20/2025 Class: II PRODUCT Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP Firmware 1.3.0 Release Configuration, Rev H SW-300689-02 Bigfoot Inject v1 Pen Cap RCAP Firmware 1.3.0 Release Configuration, Rev H The Bigfoot Unity Diabetes Management System that include the Pen Caps (Rapid-Acting Insulin...
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