Events

Recall of WELCH ALLYN AED 10

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by WELCH ALLYN CANADA LIMITED.

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
    49726
  • Event Risk Class
    II
  • Event Initiated Date
    2009-07-22
  • 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
    If a user experiences a flashing low battery status indicator and does not understand that the device can continue to be used the user might choose not to continue operating the device causing therapy to be delayed or interrupted.

Device

WELCH ALLYN AED 10
  • Model / Serial
    Model Catalog: 970308E (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 970302E (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 970311-E (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 970302F (Lot serial: MORE THAN 10 SERIAL NUMBERS)
  • Product Description
    WELCH ALLYN AED10 DEFIB MRL JUMPSTART
  • Manufacturer
    WELCH ALLYN CANADA LIMITED

Manufacturer

WELCH ALLYN CANADA LIMITED