BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-2688-2017 · Reported July 12, 2017

    Enforcement

    Recall Number
    Z-2688-2017
    Event ID
    77324
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 12, 2017
    Initiation Date
    May 16, 2017
    Classification Date
    July 6, 2017
    Termination Date
    August 22, 2018
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States

    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.

    Code Info

    Software Version VD10B

    Distribution

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

    Quantity

    US: 13 units