[pending] iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software
Pending LLM rewrite. Source: FDA_DEVICE Z-1809-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
it was found that in versions 1.3.7, 1.4.2, and 1.4.3, the Lock Screen and Limited Access Passcode Screen on the iLet graphical user interface (GUI) include certain icons displayed in the status bar that are active, thereby allowing the user to bypass those screens when those icons on the status bar are pressed, allowing unauthorized access while the device is in Limited Access Mode. A Health Risk associated with Limited access mode includes severe hypoglycemia due to unauthorized access to the iLet if someone were to make unauthorized meal announcements or stopped insulin delivery.
The recalled product
- Product
- iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software
- Manufacturer
- Beta Bionics, Inc.
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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