Health product recall

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