Voluntis: Medical Device Recall in 2018 - (Recall #: Z-0478-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Insulia Diabetes Management Companion

Product Classification:

Class II

Date Initiated: October 8, 2018

Date Posted: November 28, 2018

Recall Number: Z-0478-2019

Event ID: 81508

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.

Status: Terminated

Product Quantity: 14

Code Information:

Software version numbers 1.4.3 / 1.6.3 / 1.6.31 / 1.6.40

Distribution Pattern:

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).

Voluntary or Mandated:

Voluntary: Firm initiated