Events

Recall of Device Recall LIFEPAK 20 defibrillator/monitor

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
    37692
  • Event Risk Class
    Class 2
  • Event Number
    Z-0886-2007
  • Event Initiated Date
    2007-03-30
  • Event Date Posted
    2007-07-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-05-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51329
  • 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
    external defibrillator - Product Code MJK
  • Reason
    Defibrillator internal battery cell may contain a short which could reduce battery capacity and cause the device to shut down without warning while operating on backup (dc) battery power.
  • Action
    Firm sent letters on 03/30/2007 dated 03/2007 via certified return receipt to consignees with affected LIFEPAK 20 devices. The firm advised consignees to use the Operator's Checklist in the Operating Instructions to perform daily user tests and function checks while operating the defibrillator on battery power. In addition consignees are advised to replace their battery every 1 to 2 years.

Device

Device Recall LIFEPAK 20 defibrillator/monitor
  • Model / Serial
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distribution is worldwide. The device is designed to be used in healthcare provider facilities such as hospitals and clinic settings.
  • Product Description
    LIFEPAK 20 defibrillator/monitor. The device is an AC powered defibrillator device with battery backup. The defibrillators are primarily used by healthcare providers in device user facilities such as hospitals and clinics.
  • 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