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Omnipod 5 Controller APP
Insulet Corporation · Model M009-S-AP · UDI-DI 10385083000336
5
510(k) clearances
1
Adverse events
2
Recalls
2
Facilities
Description
Omnipod 5 Controller APP iOS V1.x
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-11 | 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 using the magnifying feature of the iPhone |
| 2025-05-23 | Insulet Corporation | Insulet Corporation is recalling Omnipod 5 iOS App, due to a software design issue in which a comma is not recognized as a decimal separator and the user cannot enter a decimal sep |
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