Philips Heartstart Defibrillators

Starting date:
March 12, 2013
Posting date:
April 9, 2013
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-26715

Recalled Products

  1. Heartstart FRX Automated External Defibrillator
  2. Philips Heartstart HS1 Onsite Defibrillator
  3. Philips Hearstart HS1 Home Defibrillator

Reason

Philips has determined that there is a need to make all owners aware that it is important to call their local Philips representative for technical support if any of their AEDS have ever emitted or begin to emit a pattern of triple chirps. Even if the user is able to clear the triple-chirp condition, the device may require additional investigation.

Affected products

A. Heartstart FRX Automated External Defibrillator

Lot or serial number
  • More than 10 numbers, contact manufacturer
Model or catalog number
  • 861304
Companies
Manufacturer
Philips Medical Systems
22100 Bothell Everett Hwy.
Bothell
98021
Washington
UNITED STATES

B. Philips Heartstart HS1 Onsite Defibrillator

Lot or serial number
  • More than 10 numbers, contact manufacturer
Model or catalog number
  • 989803169631
  • M5066A
  • M5066A-ABA
  • M5066A-ABF
  • M5068A-ABF
Companies
Manufacturer
Philips Medical Systems
22100 Bothell Everett Hwy.
Bothell
98021
Washington
UNITED STATES

C. Philips Hearstart HS1 Home Defibrillator

Lot or serial number
  • More than 10 numbers, contact manufacturer
Model or catalog number
  • M5068A
Companies
Manufacturer
Philips Medical Systems
22100 Bothell Everett Hwy.
Bothell
98021
Washington
UNITED STATES