HeartStart HS1 Home, HS1 OnSite, FRx or FR2/FR2+ AED (2021-03-03)
- Starting date:
- March 3, 2021
- Posting date:
- March 18, 2021
- 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-75147
Last updated:
2021-03-18
Affected Products
A. HEARTSTART FRX AUTOMATED EXTERNAL DEFIBRILLATOR
B. HEARTSTART FR2+ SEMI-AUTOMATIC DEFIBRILLATOR -MAIN UNIT
C. PHILIPS HEARTSTART HS1 ONSITE DEFIBRILLATOR
Reason
Philips has become aware that a HeartStart HS1 Home, HS1 OnSite, FRx or FR2/FR2+ AED in customer's possession may have been omitted from one or more previous recalls or customer information notifications. Their records indicate that a potentially affected AED was shipped to a customer and the quantity affected, but the records do not, however, contain serial number information.
Affected products
A. HEARTSTART FRX AUTOMATED EXTERNAL DEFIBRILLATOR
Lot or serial number
Not applicable.
Model or catalog number
989803138201
989803169711
Companies
- Manufacturer
-
Philips Medical Systems
22100 Bothell Everett Highway
Bothell
98021
Washington
UNITED STATES
B. HEARTSTART FR2+ SEMI-AUTOMATIC DEFIBRILLATOR -MAIN UNIT
Lot or serial number
Not applicable.
Model or catalog number
M3861A-ABA
Companies
- Manufacturer
-
Philips Medical Systems
22100 Bothell Everett Highway
Bothell
98021
Washington
UNITED STATES
C. PHILIPS HEARTSTART HS1 ONSITE DEFIBRILLATOR
Lot or serial number
Not applicable.
Model or catalog number
M5066A-ABA
M5066A-ABF
M5068A-C04
Companies
- Manufacturer
-
Philips Medical Systems
22100 Bothell Everett Highway
Bothell
98021
Washington
UNITED STATES