G6 IOS CGM MMOL App (2019-11-21)
- Starting date:
- November 21, 2019
- Posting date:
- December 20, 2019
- 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-71929
Last updated: 2019-12-20
Affected Products
G6 IOS CGM MMOL App
Reason
The G6 IOS CGM app is not properly alerting patients when the patient has enabled the alert schedule feature more than 30 days after installing the app.
Affected products
G6 IOS CGM MMOL App
Lot or serial number
Software Versions: 1.3.0, 1.3.1 , 1.3.2, 1.5.0 , 1.5.1, 1.5.2 , 1.5.3, 2.3.0
Model or catalog number
SW11586
Companies
- Manufacturer
-
DEXCOM, INC.
6340 SEQUENCE DRIVE
SAN DIEGO
92121-4356
California
UNITED STATES