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HEARTWARE VENTRICULAR ASSIST SYSTEM (2016-05-01)
- Starting date:
- May 1, 2016
- Posting date:
- June 30, 2016
- 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-59112
Affected products
A. HEARTWARE VENTRICULAR ASSIST SYSTEM
Reason
Power management software upgrade (FSCA APR2015A-SMR for abnormal power source switching). Heartware has developed this software update to enhance the communication between the controller and the batteries and to reduce the risk of premature "battery switching," and the occurrence of false battery alarms
Affected products
A. HEARTWARE VENTRICULAR ASSIST SYSTEM
Lot or serial number
CON000001 to CON210000.
Model or catalog number
1104XX
Companies
- Manufacturer
-
Heartware Inc.
14400 NW 60th Avenue
Miami Lakes
33014
Florida
UNITED STATES