Events

Recall of LIFELINE AED

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by F.A.S.T. RESCUE INC.

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
    128389
  • Event Risk Class
    I
  • Event Initiated Date
    2008-08-29
  • 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
    Devices with software 2.002 and earlier may clear a "low battery or replace battery" warning that was detected by an automatic self-test. if this occurs the operator may be unaware and the device may not shock.

Device

LIFELINE AED
  • Model / Serial
    Model Catalog: DDU-100E (Lot serial: S/N 112001001 - 112002242); Model Catalog: DDU-100A (Lot serial: S/N 112001001 - 112002242); Model Catalog: DDU-100E (Lot serial: S/N 101001000 - 101025955); Model Catalog: DDU-100A (Lot serial: S/N 101001000 - 101025955); Model Catalog: DDU-100A (Lot serial: S/N 116001000 - 116001178); Model Catalog: DDU-100E (Lot serial: S/N 116001000 - 116001178); Model Catalog: DDU-100A (Lot serial: S/N 126000975 - 126001007); Model Catalog: DDU-100E (Lot serial: S/N 126000975 - 126001007)
  • Product Classification
    Cardiovascular Devices
  • Product Description
    Debiftech DDU-100 Series AED (Lifeline)
  • Manufacturer
    F.A.S.T. RESCUE INC

Manufacturer

F.A.S.T. RESCUE INC