Events

Recall of LIFEPAK 500 AUTOMATIC EXTERNAL DEFIBRILLATOR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PHYSIO-CONTROL 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
    51829
  • Event Risk Class
    II
  • Event Initiated Date
    2013-06-18
  • 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
    As a precautionary measure the purpose of this correction is to proactively replace 14 distributed lp500 devices in canada that are potentially affected by assembly defects. there have been no reported complaints or evidence of a problem in any distributed devices.

Device

LIFEPAK 500 AUTOMATIC EXTERNAL DEFIBRILLATOR
  • Model / Serial
    Model Catalog: 3011790-XXX (Lot serial: >10 numbers contact mfg)
  • Product Description
    LIFEPAK 5003D Biphasic Automated External Defibrillator (AED)
  • Manufacturer
    PHYSIO-CONTROL INC.

Manufacturer

PHYSIO-CONTROL INC.
  • Manufacturer Address
    REDMOND
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    HC