Events

Recall of LIFEPAK CR Plus defibrillator

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
    26358
  • Event Risk Class
    Class 2
  • Event Number
    Z-0940-03
  • Event Initiated Date
    2003-05-23
  • Event Date Posted
    2003-06-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-02-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27562
  • 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
    Automated External Defibrillators (Non-Wearable) - Product Code MKJ
  • Reason
    Defibrillation therapy may be delayed or not delivered for persons needing defibrillation therapy.
  • Action
    On 5/23/03, the firm issued a recall letter to customers advising of the malfunctions and instructions to check the device to assure it is ready for use. Service representatives will visit the customer sites and replace the flex circuit in all affected devices.

Device

LIFEPAK CR Plus defibrillator
  • Model / Serial
    All serial numbers below 31058753
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    The firm distributed units worldwide. Foreign distribution includes Australia, Canada, Costa Rica, Hong Kong, India, Israel, Jamaica, Netherlands, New Zealand, Saudi Arabia, South Africa, Uruguay.
  • Product Description
    LIFEPAK CR Plus defibrillator
  • 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