Events

Recall of COOLGARD 3000 - MAIN UNIT

According to Health Canada (via FOI), this recall involved a device in Canada 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
    73122
  • Event Risk Class
    III
  • Event Initiated Date
    2005-11-09
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    System alarm may occur in connection with fluid spillage and coolgard 3000 will enter standby mode. refer to operations manual and deal with spillage before continuing therapeutic use.

Device

COOLGARD 3000 - MAIN UNIT
  • Model / Serial
    Model Catalog: (Lot serial: SERIAL# 30000011 - 30000249)
  • Product Description
    CoolGard 3000 Temperature Reg. System
  • Manufacturer
    ALSIUS CORPORATION

Manufacturer

ALSIUS CORPORATION
  • Manufacturer Address
    IRVINE
  • Source
    HC