Suresnes, N/A, France
Voluntis recalls
1 recall recorded since 2018, most recently on 8 October 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 8 October 2018
- Terminated
- 12 March 2019
- Reason
- 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).
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0478-2019
- Insulia Diabetes Management Companion
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.