BEUDAMED
    FDA Enforcement Class II Terminated

    Syngo Dynamics; Kinetdx Picture Archiving and Communications System

    Recall: Z-1601-2016 · Reported May 11, 2016

    Enforcement

    Recall Number
    Z-1601-2016
    Event ID
    73907
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 11, 2016
    Initiation Date
    April 14, 2016
    Classification Date
    May 4, 2016
    Termination Date
    March 20, 2017
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418, United States

    Description

    Syngo Dynamics; Kinetdx Picture Archiving and Communications System

    Reason

    Siemens has identified changes in default carry forward workflow using VA10B_HF03 version of Syngo Dynamics. If the template design has measurements inside a carry forward-configured report section, this will result in carrying forward the entire section of the report including data from previous studies. This may result in the physician making analysis based on the old measurements.

    Code Info

    Model Numbers: 10091637, 10091673, 10091805, 10091807 Serial Numbers: 85021, 85040, 85042, 85045, 85047, 85057, 85079, 85080, 85081, 85086, 85090, 85115, 85143, 85145, 85146, 85147, 85149, 85157, 85167, 85168, 85170, 85172, 85177, 85178, 85185, 85186, 85189, 85191, 85234, 85235, 85239, 85281, 85307, 85309, 85322, 85325, 85326, 85329, 85335, 85338, 85350, 85353, 85354, 85368, 85370, 85374, 85377, 85380, 85385, 85387, 85401, 85418, 85421, 85422, 85427, 85435, 85442, 85447, 85462, 85467, 85468, 85469, 85470, 85473, 85481, 85482, 85484, 85859, 85860, 85866, 85867, 85871, 85872, 85873, 85874, 85875, 85876, 85880, 85883, 85884, 85893, 85896, 85910, 85918

    Distribution

    Nationwide: AZ, CA, IL, IN, MA, MD, MI, MN, NJ, NY, OH, OR, PA, TN, TX, UT, WA, WI

    Quantity

    84 units