BEUDAMED
    FDA Recall 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 · Initiated March 4, 2021

    Recall

    Recall Number
    Z-1434-2021
    Event Number
    87515
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    DQK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 4, 2021
    Posted
    April 19, 2021
    Terminated
    September 30, 2024
    Address
    40 Liberty Blvd, Malvern, PA, 19355

    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

    Action

    Siemens Healthineers issued Customer Safety Advisory Notice dated 3/4/21 to affected customers via AX074/20/S. Letter states reason for recall, health risk and action to take: Siemens will restrict the Windows Service Permissions to the required level only and the IT security vulnerability of your system will be reduced via Update Instruction AX073/20/S. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. By signing this document, you are acknowledging that you have read and understand the content therein. .

    Distribution

    US Nationwide distribution.

    Quantity

    99 units