Insulet Corporation: The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field us
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Insulet Corporation
- Product
- The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneously selecting a single number on the keyboard.
- Reason / hazard
- The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneously selecting a single number on the keyboard. This causes the single digit number to duplicate. This could result in errors in manual entry of digits - examples: bolus entry, I:C ratio, bolus calculator, prior to starting the bolus insulin delivery. Therefore, this may result in over delivery of insulin which may cause hypoglycemia.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution.
- Recall initiated
- 2025-09-11
- Code info
- Omnipod 5 App Software. UDI: 10385083000459. All software versions 2.X.X
- Product quantity
- 174,013 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Acton
- State
- MA
- Country
- United States
- Event id
- 97597
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