Z-0478-2019Class II

Insulia Diabetes Management Companion

Name: Z-0478-2019 Insulia Diabetes Management Companion
Creator: Voluntis
Published: 2018-10-08
License: https://open.fda.gov/license/

Voluntis / initiated 2018-10-08 / Terminated / root cause: software

FDA source

Voluntis began a recall of Insulia Diabetes Management Companion on 2018-10-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0478-2019
Classification: Class II
Status: Terminated
Initiated: 2018-10-08
Posted: 2018-11-17
Terminated: 2019-03-12
Recalling firm: Voluntis
Product: Insulia Diabetes Management Companion
Product code: NDC Calculator, Drug Dose
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.
Root cause tag: software
FDA root cause: Software in the Use Environment
Action: On 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 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).
Product codes and lots: Software version numbers 1.4.3 / 1.6.3 / 1.6.31 / 1.6.40

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0478-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0478-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-28	2018-11-16

Product code NDC

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)