Insulet Corporation Recall 93511
Description: 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-001323- Omnipod 5 App Software Package (provided on locked-down Controllers (PT-001194 and PT-001193). Used to control an insulin pump.
Insulet Corporation Recall 93511 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0591-2024 |
| Event ID | 93511 |
| Event Description | 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-001323- Omnipod 5 App Software Package (provided on locked-down Controllers (PT-001194 and PT-001193). Used to control an insulin pump. |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the countries of Germany and UK. |
| Quantity | 27000 users |
| Recall Reason | 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. |
| Device Classification | 20240110 |
| Device Code Info | UDI/Model/NDC Number: " Omnipod 5 App Software UDI: 1038508112030 " EU locked-down Controller UDI: 10385083000190 and 10385083000206 |
| Center Classification Date | 20240104 |
| Recall Initiation Date | 20231130 |
| Recalling Firm | Insulet Corporation |
| Initial Notification | Letter |
| Similar To |