FDA-Device2018-11-28Class II
Insulia Diabetes Management Companion
Voluntis
Hazard
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.
Sold states
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).
Affected count
14
Manufactured in
22 Quai Gallieni, N/A, Suresnes, N/A, France
Products
Insulia Diabetes Management Companion
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0478-2019Don't want to check this manually?
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