Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0478-2019 — Insulia Diabetes Management Companion

U.S. FDA — Device Enforcement · France · 2018-10-08 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0478-2019
Date of alert
2018-10-08
Country / jurisdiction
France
Risk level
Class II
Risk type
recall
Brand
Voluntis
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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