Events

Recall of PHILLIPS HEARTSTART HS1 ONSITE 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
    41552
  • Event Risk Class
    II
  • Event Initiated Date
    2014-02-21
  • 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 that in a limited number of heartstart home and onsite (hs1) aeds one or both contact pins may be contaminated by residue from the soldering process. this contamination could prevent an adequate connection between the pads cartridge and the aed. if poor contact between the pads cartridge and aed occurs the device may be unable to deliver therapy in an emergency.

Device

PHILLIPS HEARTSTART HS1 ONSITE DEFIBRILLATOR
  • Model / Serial
    Model Catalog: M5068A-C01 (Lot serial: ALL); Model Catalog: M5068A-C02 (Lot serial: ALL); Model Catalog: M5066A-ABF (Lot serial: ALL); Model Catalog: M5066A-ABA (Lot serial: ALL)
  • Product Description
    PHILLIPS HEARTSTART HS1 ONSITE DEFIBRILLATOR
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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