BEUDAMED
    FDA Recall Terminated

    Welch Allyn AED 10 automatic external defibrillator and MRL Jumpstart (collectively "AED 10")

    Recall: Z-1656-2009 · Initiated April 24, 2009

    Recall

    Recall Number
    Z-1656-2009
    Event Number
    51923
    Firm
    Welch Allyn Protocol, Inc
    FEI Number
    3023750
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    April 24, 2009
    Posted
    July 6, 2009
    Terminated
    August 11, 2011
    Address
    8500 Sw Creekside Pl, Beaverton, OR, 97008

    Description

    Welch Allyn AED 10 automatic external defibrillator and MRL Jumpstart (collectively "AED 10")

    Reason

    Possible for users to misunderstand signals. The original product labeling told users that a flashing low battery indicator signals that the battery is low and requires changing soon. If a user experiences a flashing low battery status indicator and does not understand that the device can continue to be used, the user might choose not to continue operating the device, thereby causing therapy to

    Action

    The firm has developed expanded labeling for users and will revise the user manuals for software versins 2.03, 2.04, 2.05, and 2.06. Customers receiving the updated manuals will be sent a cover letter directing them to discard the original user manual and replace it with the updated manual. The April 24, 2009, cover letter will highlight the clarification of directions for use regarding what to do when a low battery indicator is displayed.

    Distribution

    Worldwide distribution: USA, Guam, Puerto Rico, Canada, Mexico, Andorra, UAE, Afghanistan, Australia, Azerbaijan, Belgium, Belarus, Bermuda, Bahrain, Brazil, British West Indies, Switzerland, China, Cyprus, Czech Republic, Germany, Denmark, Algeria, Egypt, Spain, France, French Guiana, French Lesser Antilles, Greece, Haiti, Hong Kong, Hungary, Ireland, Israel, India, Iraq, Italy, Japan, Kenya, Kyrgyz, Lebanon, Lithuania, Luxembourg, Latvia, Monaco, Malaysia, Netherlands, New Zealand, Phillipines, Pakistan, Poland, Portugal, Reunion Island, Russia, Saudi Arabia, Singapore, South Korea, Taiwan, United Kingdom, Uraguay, Yemen, and South America.

    Quantity

    46740 units