Events

Recall of COOL-CAP SYSTEM - MAIN UNIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BRAEMED LTD..

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
    38804
  • Event Risk Class
    II
  • Event Initiated Date
    2012-05-29
  • 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
    1. olympic cool-cap system's control module has experienced a frozen screen during the teratment of infants. when this occurs the on-screen information remains on display but the system is no longer providing cooling treatment. 2. there have been a small number of instances where the power supply within the cooling module of the olympic cool-cap system has failed.

Device

COOL-CAP SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: 60010 (Lot serial: serial number 7053); Model Catalog: 60010 (Lot serial: CATALOGUE/ PART NUMBER 60010)
  • Product Description
    Olympic Cool-Cap System
  • Manufacturer
    BRAEMED LTD.

Manufacturer

BRAEMED LTD.
  • Manufacturer Address
    DARTMOUTH
  • Manufacturer Parent Company (2017)
    Braemed Ltd.
  • Source
    HC