Events

Recall of Alsius CoolGard 3000 patient temperature regulation system

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Alsius Corporation.

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
    30412
  • Event Risk Class
    Class 2
  • Event Number
    Z-0258-05
  • Event Initiated Date
    2004-11-10
  • Event Date Posted
    2004-11-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-01-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35821
  • 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
    System, Hypothermia, Intravenous, Cooling - Product Code NCX
  • Reason
    Product alarms that there may be a power supply interruption.
  • Action
    Firm removed products from use for repair on 11/10/2004.

Device

Alsius CoolGard 3000 patient temperature regulation system
  • Model / Serial
    Serial numbers 30000160 and 30000132
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    IL and NC. Specifically, Rush University Medical Center, Chicago IL and Duke University medical Center, Durham NC.
  • Product Description
    Alsius CoolGard 3000 patient temperature regulation system
  • Manufacturer
    Alsius Corporation

Manufacturer

Alsius Corporation
  • Manufacturer Address
    Alsius Corporation, 15770 Laguna Canyon Rd Ste 150, Irvine CA 92618-3111
  • Source
    USFDA