June 20, 2025

Jun

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

June 20, 2025Allison PateNews

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...

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

Upcoming Public Courses

Corporate Office

Day

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

Upcoming Public Courses

Corporate Office