Events

Recall of PHILLIPS HEARTSTART HS1 HOME DEFIBRILLATOR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PHILIPS ELECTRONICS LTD..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    28123
  • Event Risk Class
    II
  • Event Initiated Date
    2018-02-23
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Philips has become aware of a specific issue with one of the electric components (a resistor) in approximately 660000 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.

Device

PHILLIPS HEARTSTART HS1 HOME DEFIBRILLATOR
  • Model / Serial
    Model Catalog: M5068A (Lot serial: N/A); Model Catalog: M-5066A-ABA (Lot serial: N/A); Model Catalog: M5068A-ABF (Lot serial: N/A); Model Catalog: M5066A-ABF (Lot serial: N/A); Model Catalog: 989803169631 (Lot serial: N/A); Model Catalog: M5066A (Lot serial: N/A); Model Catalog: 861304 (Lot serial: N/A)
  • Product Description
    PHILIPS HEARTSTART HS1 HOME DEFIBRILLATOR;PHILIPS HEARTSTART HS1 ONSITE DEFIBRILLATOR;HEARTSTART FRX AUTOMATED EXTERNAL DEFIBRILLATOR
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

PHILIPS ELECTRONICS LTD.
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    HC