Health product recall

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