BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0426-2014 · Reported December 4, 2013

    Enforcement

    Recall Number
    Z-0426-2014
    Event ID
    65985
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Custom Ultrasonics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 4, 2013
    Initiation Date
    March 12, 2013
    Classification Date
    November 27, 2013
    Termination Date
    June 26, 2014
    Address
    144 Railroad Dr, N/A, Ivyland, PA, 18974-1449, United States

    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.

    Code Info

    Multiple serial numbers

    Distribution

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

    Quantity

    118