Beta Bionics, Inc.: Alternate Controller Enabled Insulin Infusion Pump
Updated 5 hours ago ()
The reason for the recall is: it was found in version 3.3.6 of the iLet ACE Pump firmware and all previous releases that a screen unlock failure could occur when the user successfully slides the unlock slider on the Lock Screen, no screen transition occurs, and the user remains on the Lock Screen. Because the user cannot exit the Lock Screen, the user is unable to perform a cartridge change or meal announcement. If this occurs and therapy is in progress, therapy will continue normally until the insulin cartridge is depleted. The user will be unable to perform a cartridge change or a meal announcement and will be stuck on the screen until the battery fully drains. This can lead to hyperglycemia.
- Tags
- FDA recall, medical device, class 2, Clinical Chemistry, Software design, Open, Classified
- Related exam domains
- CISSP 3: Security Architecture and Engineering; CISSP 8: Software Development Security
- Source record id
- Z-2513-2026
- First seen by InfoSec Signals
- Sep 23, 2026
Source: openFDA device recalls, U.S. Food and Drug Administration about this source more from it
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