BEUDAMED
    FDA Recall Terminated

    AXIOM Artis Systems VB23A-VB23H with Perivision functionality, Model Numbers: 5904433,5904649, 5904466, 5904441, 5904656, 7728350, and 7007755 Angiographic X-ray System

    Recall: Z-0144-2011 · Initiated September 9, 2010

    Recall

    Recall Number
    Z-0144-2011
    Event Number
    56754
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    IZI
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 9, 2010
    Posted
    October 26, 2010
    Terminated
    September 29, 2012
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355

    Description

    AXIOM Artis Systems VB23A-VB23H with Perivision functionality, Model Numbers: 5904433,5904649, 5904466, 5904441, 5904656, 7728350, and 7007755 Angiographic X-ray System

    Reason

    Sporadic system crash while Perivision is performed.

    Action

    Siemens issued an Urgent Field Safety Notice to all customers. The letter informed customers of the potential issues and provided additional information on the implemented resolution. To resolve the problem, a system update was to be installed on each affected system under Update Instructions AX054/10/S. For questions phone (610) 448-3237.

    Distribution

    USA - Nationwide Distribution

    Quantity

    286 units