BEUDAMED
    FDA Enforcement Class II Terminated

    syngo.plaza, Model number 10592457. Intended use: radiological image processing system.

    Recall: Z-2275-2012 · Reported September 5, 2012

    Enforcement

    Recall Number
    Z-2275-2012
    Event ID
    62679
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 5, 2012
    Initiation Date
    July 18, 2012
    Classification Date
    August 27, 2012
    Termination Date
    January 24, 2014
    Address
    51 Valley Stream Pkwy, N/A, Malvern, PA, 19355, United States

    Description

    syngo.plaza, Model number 10592457. Intended use: radiological image processing system.

    Reason

    There is a potential malfunction in which a miscalculation occurs for images with pixel depth values greater that 12 bit in certain functions.

    Code Info

    Serial Numbers: 100263, 100401, 100177, 100138, 100174, 100219, 100406, 100249, 200040, 100201, 100198, 100181, 100301, & 100146.

    Distribution

    Nationwide Distribution -- CA, FL, GA, MA, MN, MO, NJ, NY, OH, WA, and WI.

    Quantity

    14