Insulia (2018-10-11)
- Starting date:
- October 11, 2018
- Posting date:
- November 28, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-68376
Affected products
Insulia
Reason
Bug impacting the mobile Android version of the patient account that could lead under certain and rare conditions to a hypoglycaemia event not being taken into account by the basal calculator when launched. No adverse event related.
Affected products
Insulia
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
A_1.6
Companies
- Manufacturer
-
VOLUNTIS S.A.
58 AVENUE DE WAGRAM
PARIS
75017
FRANCE