BEUDAMED
    FDA Enforcement Class II Terminated

    Sensis/ Sensis Vibe Hemo systems with VD12A software as follows: Dedicated SIS Server- 6648153 Sensis Post-Processing Workstation- 6648161 Sensis- 10764561 VM Virtual Server- 10765502 Sensis High-End Servers- 10910620 Sensis Vibe Hemo- 11007641 Sensis Vibe Combo- 11007642 Sensis Vibe is a recording and procedure data management system for interventional cardiology, interventional radiology, surgical procedures performed in a hybrid OR and electrophysiology

    Recall: Z-1434-2021 · Reported April 28, 2021

    Enforcement

    Recall Number
    Z-1434-2021
    Event ID
    87515
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 28, 2021
    Initiation Date
    March 4, 2021
    Classification Date
    April 19, 2021
    Termination Date
    September 30, 2024
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355, United States

    Description

    Sensis/ Sensis Vibe Hemo systems with VD12A software as follows: Dedicated SIS Server- 6648153 Sensis Post-Processing Workstation- 6648161 Sensis- 10764561 VM Virtual Server- 10765502 Sensis High-End Servers- 10910620 Sensis Vibe Hemo- 11007641 Sensis Vibe Combo- 11007642 Sensis Vibe is a recording and procedure data management system for interventional cardiology, interventional radiology, surgical procedures performed in a hybrid OR and electrophysiology

    Reason

    Due to the configuration of certain Windows Service Permissions within the operating systems of the Sensis/ Sensis Vibe computer, there is a risk for exposure of sensitive information, manipulation of data, or Denial of Service attacks and could result in incorrect diagnostic or therapeutic decisions

    Code Info

    Serial Numbers: As of 8/24/22 (Updated) 10661 11657 14000 14012 14123 14312 14603 14804 14900 14902 15010 15130 15135 15136 15819 15829 15902 15903 15904 15908 15913 15915 15916 15917 15920 15923 15924 15925 15926 15927 15928 18900 18901 100208 100209 100216 100306 100309 102138 102145 102147 102221 102326 103014 103019 103022 103039 103040 103042 103047 103048 103079 103080 103082 103086 103088 103089 103090 103108 103111 103114 103115 103116 103117 103119 103123 103124 103130 103131 103139 103144 103145 103148 103152 103160 103161 103166 103167 103168 103170 103171 103172 103173 103177 103178 103182 103184 103186 103189 103193 103194 103196 103198 103199 103200 103208 103216 123004 123021

    Distribution

    US Nationwide distribution.

    Quantity

    99 units