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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- 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
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