Events

Recall of Device Recall LIFEPAK

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Physio Control Corp.

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
    29027
  • Event Risk Class
    Class 2
  • Event Number
    Z-0971-04
  • Event Initiated Date
    2004-05-05
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-01-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32995
  • 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 dc power adapter may fail to charge lifepak nicd 2.4 ah batteries used with the lifepak 12 defibrillator/monitor.
  • Action
    On 5/5/04 the firm issued a letter to consignees advising of the problem and that a service representative will contact them regarding replacement of the DC Power Adapter.

Device

Device Recall LIFEPAK
  • Model / Serial
    Part numbers: VLP12-09-000031 through VLP12-09-000048. Serial numbers: 1563 through 5232 (non-contiguous)
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The firm distributed devices to medical facilities, fire departments (first responders).
  • Product Description
    DC Power Adapter for use with the LIFEPAK 12 defibrillator/monitor.
  • Manufacturer
    Medtronic Physio Control Corp

Manufacturer

Medtronic Physio Control Corp
  • Manufacturer Address
    Medtronic Physio Control Corp, 11811 Willows Rd NE, Redmond WA 98073
  • Source
    USFDA