Events

Recall of Device Recall LIFEPAK 20

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Emergency Response Systems, 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
    36493
  • Event Risk Class
    Class 2
  • Event Number
    Z-0295-2007
  • Event Initiated Date
    2006-03-16
  • Event Date Posted
    2006-12-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-03-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48740
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    automatic external defibrillator - Product Code LDD
  • Reason
    Lifepak 20 may lock-up when attempting to power-up on dc within 2 seconds after removing ac power.
  • Action
    Letter dated December 2006 alerts users to the lock-up problem, and suggesting a procedure to prevent lock-up. Firm promised another letter in January 2007 detailing the plan to provide software upgrade.

Device

Device Recall LIFEPAK 20

Manufacturer

Medtronic Emergency Response Systems, Inc.
  • Manufacturer Address
    Medtronic Emergency Response Systems, Inc., 11811 Willows Rd Ne, Redmond WA 98052-2003
  • Source
    USFDA