Philips HeartStart OnSite and Home Defibrillator and HeartStart FRx Automated External Defibrillator (2018-02-23)
- Starting date:
- February 23, 2018
- Posting date:
- March 13, 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-66146
Affected products
- HEARTSTART FRX AUTOMATED EXTERNAL DEFIBRILLATOR
- PHILIPS HEARTSTART HS1 ONSITE DEFIBRILLATOR
- PHILIPS HEARTSTART HS1 HOME DEFIBRILLATOR
Reason
Philips has become aware of a specific issue with one of the electric components (a resistor) in approximately 660,000 AEDs that were manufactured between 2002-2013. Virtually all of these resistor-related failures were detected through the device's automatic self-testing, alerting the user by issuing audible chirps. The in-use reliability of these AEDs is greater than 99.9% when the AED determines a cardiac arrest victim is in need of shock therapy.
Affected products
A. HEARTSTART FRX AUTOMATED EXTERNAL DEFIBRILLATOR
Lot or serial number
Not applicable
Model or catalog number
861304
Companies
- Manufacturer
-
Philips Medical Systems
22100 Bothell Everett Highway
Bothell
98021
UNITED STATES
B. PHILIPS HEARTSTART HS1 ONSITE DEFIBRILLATOR
Lot or serial number
Not applicable
Model or catalog number
989803169631
M-5066A-ABA
M5066A
M5066A-ABF
M5068A-ABF
Companies
- Manufacturer
-
Philips Medical Systems
22100 Bothell Everett Highway
Bothell
98021
UNITED STATES
C. PHILIPS HEARTSTART HS1 HOME DEFIBRILLATOR
Lot or serial number
Not applicable
Model or catalog number
M5068A
Companies
- Manufacturer
-
Philips Medical Systems
22100 Bothell Everett Highway
Bothell
98021
UNITED STATES