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Dexcom G4 Platinum Continuous Glucose Monitoring System (2016-03-15)
- Starting date:
- March 15, 2016
- Posting date:
- March 30, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-57700
Affected products
- Dexcom G4 Continuous Glucose Monitoring System - Receiver
- DEXCOM G4 CONTINUOUS GLUCOSE MONITORING SYSTEM - Replacement
- DEXCOM G4 PLATINUM RECEIVER KIT
Reason
Audiable alert and alarms on the Dexcom G4 and G4 PLATINUM CGM system receiver may fail (intermittent audio and no audio).
Affected products
A. Dexcom G4 Continuous Glucose Monitoring System - Receiver
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
STK-GL-105
Companies
- Manufacturer
-
DEXCOM, INC.
6340 SEQUENCE DRIVE
SAN DIEGO
92121-4356
California
UNITED STATES
B. DEXCOM G4 CONTINUOUS GLUCOSE MONITORING SYSTEM - Replacement
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
STR-GL-101
Companies
- Manufacturer
-
DEXCOM, INC.
6340 SEQUENCE DRIVE
SAN DIEGO
92121-4356
California
UNITED STATES
C. DEXCOM G4 PLATINUM RECEIVER KIT
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
- STK-GL-113
- STR-GL-102
Companies
- Manufacturer
-
DEXCOM, INC.
6340 SEQUENCE DRIVE
SAN DIEGO
92121-4356
California
UNITED STATES