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Recall Observatory FDA recall evidence

Device product

Insulia Diabetes Management Companion

Z-0478-2019

October 08, 2018

Class II

Product summary

Firm
Voluntis
Event
Event 81508
Status
Terminated
Classification
Class II
Quantity
14
Official record key
device-enforcement:Z-0478-2019

Official wording

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.

Code information: Software version numbers 1.4.3 / 1.6.3 / 1.6.31 / 1.6.40

Distribution pattern: 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).

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.