The Recall Desk
SevereFDA (Devices)·Z-0478-2019·Announced 2018-11-28

Voluntis Recalls Insulia Diabetes Management Companion Due to Calculator Bug

Voluntis is recalling the Insulia Diabetes Management Companion because a bug in the Android basal calculator could cause hypoglycemia. An update is available to resolve the issue.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is Class II, and the source text explicitly states the bug could lead to 'high-impact hypoglycemia,' which constitutes a significant injury risk under the rubric.

Plain-English summary

Voluntis is recalling the Insulia Diabetes Management Companion due to a software issue identified in the Android version of the application. The bug affects the basal calculator and could lead to hypoglycemia, ranging from low-impact to high-impact depending on the circumstances.

The recall involves 14 units distributed to accounts in Arizona, Massachusetts, Michigan, Ohio, Tennessee, and Vermont. The product was also distributed to Canada and France, though French customers are not affected. The affected software version numbers are 1.4.3, 1.6.3, 1.6.31, and 1.6.40.

A new update of Insulia (version 1.6.42) is now available which resolves this issue. Users should update their software to the latest version to mitigate the risk of hypoglycemia.

The recalled product

Product
Insulia Diabetes Management Companion
Manufacturer
Voluntis
Category
Medical Device — Diabetes Management Software
Hazard
Affected units
14

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Software version numbers 1.4.3 / 1.6.3 / 1.6.31 / 1.6.40

Distribution

Distributed in 5 states:

Related recalls

Same hazard · hypoglycemia

See all →