Events

Recall of WELCH ALLYN AED 20 WITH NON-RECHARGEABLE LITHIUM BATTERY

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ROXON MEDI-TECH 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
    44109
  • Event Risk Class
    I
  • Event Initiated Date
    2006-06-28
  • 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
    Defib comm fail self test failed error message displayed as a result of an electrical connection inside failing to analyze the patient's heart rhythm and deliver appropriate therapy.

Device

WELCH ALLYN AED 20 WITH NON-RECHARGEABLE LITHIUM BATTERY
  • Model / Serial
    Model Catalog: 972211 (Lot serial: ); Model Catalog: 972214 (Lot serial: ); Model Catalog: 972216 (Lot serial: ); Model Catalog: 972215 (Lot serial: )
  • Product Classification
    Cardiovascular Devices
  • Product Description
    AED 20 AUTOMATIC EXTERNAL DEFIBRILLATOR
  • Manufacturer
    ROXON MEDI-TECH LTD.

Manufacturer

ROXON MEDI-TECH LTD.