BEUDAMED
    FDA Enforcement Class II Terminated

    CoolBlue Hyper-Hypothermia System- body hypothermia system Model: Innercool - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.

    Recall: Z-0419-2020 · Reported November 27, 2019

    Enforcement

    Recall Number
    Z-0419-2020
    Event ID
    83464
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cincinnati Sub-Zero Products LLC, a Gentherm Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 27, 2019
    Initiation Date
    July 2, 2019
    Classification Date
    November 18, 2019
    Termination Date
    June 22, 2020
    Address
    12011 Mosteller Rd, N/A, Cincinnati, OH, 45241-1528, United States

    Description

    CoolBlue Hyper-Hypothermia System- body hypothermia system Model: Innercool - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.

    Reason

    Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage. Additionally, a caution was added and clarifications were made regarding the use of the Automatic modes

    Code Info

    Serial Numbers: 073-CB-00001 through 162-CB-00294

    Distribution

    Worldwide distribution - US Nationwide and countries of Afghanistan, Argentina, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Belgium, Bhutan, Brazil, Brunei, Canada Chile, China, Colombia, Costa Rica, Ecuador, Egypt, El Salvador, France, Germany, Guatemala, Hong Kong, India, Indonesia, Israel, Italy, Japan, Kazakhstan, Kenya, Kuwait, Lebanon, Malaysia, Mexico, Morocco, Nepal, Netherlands, New Zealand, Oman, Pakistan, Palestine, Panama, Philippines, Qatar, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, Venezuela, Vietnam.

    Quantity

    5291