BEUDAMED
    FDA Recall Terminated

    Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; LANTIS 8.3 Commander The intended use of the linear accelerator is to deliver x-ray radiation for therapeutic treatment of cancer.

    Recall: Z-1840-2014 · Initiated May 6, 2014

    Recall

    Recall Number
    Z-1840-2014
    Event Number
    68379
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Use error
    Initiated
    May 6, 2014
    Posted
    June 20, 2014
    Terminated
    December 15, 2014
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355

    Description

    Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; LANTIS 8.3 Commander The intended use of the linear accelerator is to deliver x-ray radiation for therapeutic treatment of cancer.

    Reason

    There is a potential risk when using LANTIS OIS System client software with operating systems for which it has not been validated and released, resulting in incorrectly stored data, such as treatment records, and LANTIS database corruption.

    Action

    Siemens sent an Urgent Medical Device Correction Field Safety Notice dated was sent to end users on/about May 6, 2014, to notify them of the safety issue and provide instructions to avoid potential risks. Customers were instructed to make sure all computers with the LANTIS client software installed are running on an operating system that was validated by Siemens for opration with LANTIS, e.g. Microsoft Windows XP Service Pack 3 (SP3). Customers were asked to include the Field Safety Notice in their System Owner Manual chapter "Safety Advisory Letters" where it should remain and that all affected personnel affected be informed. For questions regarding this recall call 1-610-219-6300.

    Distribution

    Nationwide Distribution

    Quantity

    108