BEUDAMED
    FDA Recall Terminated

    syngo Dynamics version 9.0, Siemens Medical Solutions, USA, Inc., Ann Arbor, MI. The syngo Dynamics is a picture archiving and communications system intended for acceptance, transfer, display, storage, archiving and manipulation of digital medical images, including quantification and report generation. It is not intended to be used for the reading of mammography images.

    Recall: Z-2293-2011 · Initiated March 24, 2011

    Recall

    Recall Number
    Z-2293-2011
    Event Number
    58545
    Firm
    Siemens Medical Solutions, USA, Inc
    FEI Number
    3003304172
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 24, 2011
    Posted
    May 25, 2011
    Terminated
    July 10, 2012
    Address
    400 Morgan Rd, Ann Arbor, MI, 48108

    Description

    syngo Dynamics version 9.0, Siemens Medical Solutions, USA, Inc., Ann Arbor, MI. The syngo Dynamics is a picture archiving and communications system intended for acceptance, transfer, display, storage, archiving and manipulation of digital medical images, including quantification and report generation. It is not intended to be used for the reading of mammography images.

    Reason

    If one or more graphs are in a table on the report, and if any of those graphs are deleted, it may lead to reports failing to save and/or marking the study as read might leave the study in an unread state or might mark the study as read but leave the report with a "Preliminary" watermark displayed.

    Action

    The firm, SIEMENS, sent a "Customer Safety Advisory Notice" letter dated March 24, 2011 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to place graphs in sections and not tables in the report; avoid deleting graphs from the reports in run-time and include this safety advisory notice in their operator's manual where it should remain until the service patch is applied. SIEMENS will be issuing a service patch to fix the defect. The letter states the patch will be available in the next few weeks. If you have any questions, call +1 (734) 205-2400.

    Distribution

    Nationwide distribution: USA including states of: CA, CT, FL, ID, MD, MI, MN, NJ, NY and PA.

    Quantity

    29 devices