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
    32492
  • Event Risk Class
    Class 2
  • Event Number
    Z-0984-05
  • Event Initiated Date
    2005-06-17
  • Event Date Posted
    2005-07-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-05-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40187
  • 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
    Dc-Defibrillator, Low-Energy, (Including Paddles) - Product Code LDD
  • Reason
    The defibrillator may not operate if the device is turned on during an ac loss alert.
  • Action
    On 6/17/05 the firm issued a medical device correction letter to customers advising of the problem, explained what to do if the situation occurs, and that a service representative will visit and install new software.

Device

Device Recall LIFEPAK 20
  • Model / Serial
    Various, noncontiguous serial numbers. Part numbers: 3202487-xxxd and 3202488-xxx.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Devices were distributed to hospitals and medical centers worldwide.
  • Product Description
    LIFEPAK 20 defbrillator/monitor
  • Manufacturer
    Medtronic Emergency Response Systems, Inc.

Manufacturer

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