BEUDAMED
    FDA Recall Terminated

    Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161 --- Programmable diagnostic computer,

    Recall: Z-2688-2017 · Initiated May 16, 2017

    Recall

    Recall Number
    Z-2688-2017
    Event Number
    77324
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    DQK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 16, 2017
    Terminated
    August 22, 2018
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    Description

    Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161 --- Programmable diagnostic computer,

    Reason

    Software error. In Sensis Vibe systems with software version VD10B, a software error can result in: problems generating a report and/ or - information from different examinations of the same patient being combined into one report. --- The error causes information from two examinations to be combined into one report. This does not result in a hazardous situation; however, if the erroneous report has been used for treatment or diagnosis, this can potentially result in an incorrect treatment or diagnosis.

    Action

    Siemens sent an Customer Safety Advisory Notice dated May 16, 2017, was mailed to all users on May 16, 2017. The letter informs customers of the software issue and potential impact. Siemens Medical Solutions will contact users to make arrangements to update the system with updated software to correct the issue. For further questions, please call (610) 448-6461.

    Distribution

    US Distribution to the states of : IN, MI, IA

    Quantity

    US: 13 units