Company: Voluntis
Date of Enforcement Report: 11/16/2018
Class II:

PRODUCT
Insulia Diabetes Management Companion

Recall Number: Z-0478-2019

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/MANUFACTURER
Voluntis, Suresnes , France on 10/8/2018. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
14

DISTRIBUTION
Distributed to accounts in Arizona, Masachusetts, Michigan, Ohio, Tennessee, and Vermont. International distribution to Canada and France (however, French customers are not affected by this recall).