Insulet Corporation: Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current). US: PT-000599- Omnipod 5 App Software Package (provided through Google Play), EU: PT-00

Hazard

The bolus calculator is not recording the decimal point if it is the first value entered when changing a bolus dose. This may lead to an over-delivery of insulin to the user if the user does not recognize the error on the bolus calculator screen or the confirmation screen prior to starting the bolus.

Details from the source

Reason for recall: The bolus calculator is not recording the decimal point if it is the first value entered when changing a bolus dose. This may lead to an over-delivery of insulin to the user if the user does not recognize the error on the bolus calculator screen or the confirmation screen prior to starting the bolus. Distribution: Worldwide distribution - US Nationwide and the countries of Germany and UK. Quantity: 27000 users Lot/code info: UDI/Model/NDC Number: " Omnipod 5 App Software UDI: 1038508112030 " EU locked-down Controller UDI: 10385083000190 and 10385083000206

UPC codes

1038508112030, 10385083000190, 10385083000206

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.