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U.S. Department of Health and Human Services

Class 2 Device Recall Insulia Diabetes Management Companion

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 Class 2 Device Recall Insulia Diabetes Management Companionsee related information
Date Initiated by FirmOctober 08, 2018
Create DateNovember 17, 2018
Recall Status1 Terminated 3 on March 12, 2019
Recall NumberZ-0478-2019
Recall Event ID 81508
510(K)NumberK170669 K172177 
Product Classification Calculator, drug dose - Product Code NDC
ProductInsulia Diabetes Management Companion
Code Information Software version numbers 1.4.3 / 1.6.3 / 1.6.31 / 1.6.40
FEI Number 3013530341
Recalling Firm/
Manufacturer		 Voluntis
22 Quai Gallieni
Suresnes France
For Additional Information ContactInsulia Hotline
866-4678542
Manufacturer 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.
FDA Determined
Cause 2		Software in the Use Environment
ActionOn October 15, 2018, patients were notified that they could download the new version of the application from the Google Play Store. The notification was made through an automated message displayed on the application screen of all impacted patients requesting them to update their Insulia application. Patients were informed that the new version of the app resolved a an issue with the basal calculator identified on the Android version of the application. Patients who do not upgrade to the new version by November 9, 2018 will be blocked from using the app until they upgrade. For technical assistance or if you have any questions, please contact the Insulia support hotline.
Quantity in Commerce14
DistributionDistributed 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).
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = NDC
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