iLet Bionic Pancreas, REF: BB1001
Publicado el 24 de junio de 2026 · Inicio del retiro: 23 de septiembre de 2025
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Beta Bionics, Inc.
- Distribuidor
- US: WI, HI, OH, ME, CO, NJ, NE, KY, SC, CA, TX, NH, NY, WA, PA, MD, FL, IA, GA, MI, VT, TN, IL, IN, KS, MA, LA, MS, NC, CT, MN, VA, OK, AR, AZ, MO, MT, RI, DC, NM, OR, ID, NV, AK, ND, DE, WV, WY, SD, UT, AL
- Lote
- iLet ACE Pump firmware BOM000072 Rev C (version 3.3.6) and BOM000072 Rev B (version 3.3.4)
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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