Z-0478-2019 Class II Terminated
FDA device recall Z-0478-2019 was initiated by Voluntis on October 8, 2018 and is designated Class II. 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 cir… The recall status is terminated (terminated March 12, 2019). Affected quantity: 14.
Recall Details
- Product Type
- Devices
- Report Date
- November 28, 2018
- Initiation Date
- October 8, 2018
- Termination Date
- March 12, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14
Product Description
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 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).
Code Information
Software version numbers 1.4.3 / 1.6.3 / 1.6.31 / 1.6.40