Recall Z-0478-2019— Voluntis
Class II · Terminated
Class II FDA medical device recall by Voluntis, initiated 2018-10-08, terminated 2019-03-12. It names 2 FDA 510(k) clearances: K172177, K170669. 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..
- Recalling firm
- Voluntis
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-10-08
- Terminated
- 2019-03-12
- Firm location
- Suresnes, N/A, France
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Insulia Diabetes Management Companion
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.