# FDA recall Z-0478-2019

> **Voluntis** · Class II · device recall initiated 2018-10-08.

## Product

Insulia Diabetes Management Companion

## 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.

## 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).

## Key facts

- **Recall number:** Z-0478-2019
- **Recalling firm:** Voluntis
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-10-08
- **Report date:** 2018-11-28
- **Termination date:** 2019-03-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Suresnes, N/A, France

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0478-2019

## Citation

> AI Analytics. FDA recall Z-0478-2019. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-0478-2019. Source: US FDA. Licensed CC0.

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