Events

Recall of POWERHEART G3 PLUS AUTOMATIC

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CARDIAC SCIENCE CORPORATION.

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
    104317
  • Event Risk Class
    II
  • Event Initiated Date
    2010-01-11
  • 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
    Cardiac science identified 65 reported early failures of contact resistance in the k302 relay of the g3 series aed product line over a 3 year time period ending may 2009. these failures occur within 200 days of shipment. the shipment date corresponds to the date at which the device is activated and an automated daily self-test begins.

Device

POWERHEART G3 PLUS AUTOMATIC
  • Model / Serial
    Model Catalog: 9390A-501 (Lot serial: Serial # 4261144); Model Catalog: 9390A-501 (Lot serial: Serial # 4261411); Model Catalog: 9390A-501 (Lot serial: Serial # 4261416); Model Catalog: 9390A-501 (Lot serial: Serial # 4261417); Model Catalog: 9390A-501 (Lot serial: Serial # 4261123); Model Catalog: 9390A-501 (Lot serial: Serial # 4261383); Model Catalog: 9390A-501 (Lot serial: Serial # 4261387); Model Catalog: 9390A-501 (Lot serial: Serial # 4261403); Model Catalog: 9390A-501 (Lot serial: Serial # 4261408)
  • Product Description
    Powerheart AED G3
  • Manufacturer
    CARDIAC SCIENCE CORPORATION

Manufacturer

CARDIAC SCIENCE CORPORATION