BEUDAMED
    FDA Recall Terminated

    Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector.

    Recall: Z-0426-2014 · Initiated March 12, 2013

    Recall

    Recall Number
    Z-0426-2014
    Event Number
    65985
    Firm
    Custom Ultrasonics, Inc.
    FEI Number
    2523209
    Product Code
    KOG
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 12, 2013
    Posted
    November 27, 2013
    Terminated
    June 26, 2014
    Address
    144 Railroad Dr, Ivyland, PA, 18974-1449

    Description

    Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector.

    Reason

    Certain System 83 Plus 2 and System 83 Plus 9 units running the Windows 7 operating system were not fully validated prior to distribution.

    Action

    A notification letter, dated February 26, 2013, was sent to direct accounts to inform them of the recall and that technicians would visit facilities to replace the Windows 7 operating system with an appropriately validated Windows XP operating system.

    Distribution

    Worldwide Distribution: USA (nationwide) and Internationally to: Canada, Slovakia Republic, Sydney and Peru.

    Quantity

    118