Events

Recall of Alsius CoolGard 3000 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
    32762
  • Event Risk Class
    Class 3
  • Event Number
    Z-1397-05
  • Event Initiated Date
    2005-07-25
  • Event Date Posted
    2005-08-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-01-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40783
  • 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
    Firm wants users to be aware not to leave the units in standby mode for more than an hour in rooms in excess of 75 f due to risk of an alarm mode being generated due to overheating.
  • Action
    Firm will be sending letters of caution to all users that reemphasizes labeling beginning 7/25/2005. New software is being developed which will include a change to maintain STANDBY coolant temperature regulation indefinitely, removing any risk of failure.

Device

Alsius CoolGard 3000 Temperature Regulation System
  • Model / Serial
    All units manufactured before April 12, 2005.
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and in Uruguay, Netherlands, Switzerland, Spain, Poland, China, Norway, Malasia, Italy, Ireland, greece, Germany, France, Finland, Canada, Belgium, Austria, Bahamas,
  • Product Description
    Alsius CoolGard 3000 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