FDA Device recall Z-0478-2019
Insulia Diabetes Management Companion
- FDA Device
- Class II
- terminated
- Published 2018-11-28
On 2018-11-28 the FDA classified a Class II recall of Insulia Diabetes Management Companion by Voluntis, citing the firm identified an issue with the basal calculator identified on the Android version of the Insulia application. The bug could lead from low-impact to high-impact hypoglycemia….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0478-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-10-08 |
| Published | 2018-11-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Voluntis |
| Distribution | AZ, MI, OH, TN, VT |
Product
Insulia Diabetes Management Companion
Reason
The firm identified an issue with the basal calculator identified on the Android version of the Insulia application. The bug could lead from low-impact to high-impact hypoglycemia depending on the circumstances. A new update of Insulia is now available (version 1.6.42), which resolves this issue.
Identifiers
| code_info | Software version numbers 1.4.3 / 1.6.3 / 1.6.31 / 1.6.40 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0478-2019%22
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