BEUDAMED
    FDA Enforcement Class II Terminated

    Syngo Imaging version V31 (model # 10014063) is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images. It supports the physician in diagnosis and treatment planning.

    Recall: Z-0405-2018 · Reported January 31, 2018

    Enforcement

    Recall Number
    Z-0405-2018
    Event ID
    78911
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 31, 2018
    Initiation Date
    July 25, 2017
    Classification Date
    January 23, 2018
    Termination Date
    July 23, 2018
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States

    Description

    Syngo Imaging version V31 (model # 10014063) is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images. It supports the physician in diagnosis and treatment planning.

    Reason

    Siemens is releasing a letter to inform about potential data loss relevant to diagnosis.

    Code Info

    material 10014063 Serial numbers: 1334, 1065, 1417, 1043 1353,1491,1496, 1316, 1279, 1116, 1090, 1081, 1310, 1226, 1396, 1107, 1343, 1198, 1432, 1058, 1082 1055, 1049, 1329, 1490, 1083, 1053, 1079, 1218, 1451, 1386, 1064, 1500, 1005, 1322, 1074. Updated version 31 contains 2 improvements on front end for usability, such as query enhancements and calibration improvements

    Distribution

    USA (nationwide) Distribution to the states of: MA, CA, NC, WI, NY, NE, PA, AL, NJ, MO, MI, TX, MS, KS, LA, CT, MD, LA, CO, OK, MN and TN.

    Quantity

    36 units.