BEUDAMED
    FDA Recall Terminated

    Radical Handheld Pulse Oximeter

    Recall: Z-0933-05 · Initiated June 10, 2005

    Recall

    Recall Number
    Z-0933-05
    Event Number
    32384
    Firm
    Masimo Corporation
    FEI Number
    3001452206
    Product Code
    DQA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 10, 2005
    Posted
    June 25, 2005
    Terminated
    June 17, 2008
    Address
    40 Parker, Irvine, CA, 92618-1604

    Description

    Radical Handheld Pulse Oximeter

    Reason

    Speaker component failure resulting in ceasation of an audible alarm even though the condition continues that caused the alarm.

    Action

    Recall was by letter to all customers who received units made before 12/11/01. They are to return for repair or have them fixed by an Authorized Masimo Service Representative.

    Distribution

    Nationwide and Korea, Hong Kong, Canada, New Zealand, Thailand, Argentina, Portugal, Malaysia, Ireland, Australia, japan, France, El Salvador, South Africa, UAE-Saudi Arabia, Germany, Mexico, Unitied Kingdom, Singapore, Germany, Kuwait, Chile, Spain, Iceland, Italy, Poland, Sweden, Norway, Venezuela, Lithuania, Czech Republic, Belgium, Neterlands, Austria, Switzerland, Egypt, Greece, France Taiwan.

    Quantity

    8,110