BEUDAMED
    FDA Recall Terminated

    DICOM Export Format for Sum Dose with Velocity v3.0.0. A stand-alone software product that provides the oncology care specialists (physicians, physicists, dosimetrists, etc.) a means for comparison of medical imaging data from multiple DICOM conformant imaging modality sources. It allows the display, annotating, volume rendering, registration and fusing of medical images as an aid during use by diagnostic radiology, oncology, radiation therapy planning and other medical specialties.

    Recall: Z-1275-2014 · Initiated July 25, 2013

    Recall

    Recall Number
    Z-1275-2014
    Event Number
    67615
    Firm
    Velocity Medical Solutions, LLC
    FEI Number
    3007157255
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 25, 2013
    Posted
    March 25, 2014
    Terminated
    September 11, 2014
    Address
    75 5th St Nw, Atlanta, GA, 30308-1019

    Description

    DICOM Export Format for Sum Dose with Velocity v3.0.0. A stand-alone software product that provides the oncology care specialists (physicians, physicists, dosimetrists, etc.) a means for comparison of medical imaging data from multiple DICOM conformant imaging modality sources. It allows the display, annotating, volume rendering, registration and fusing of medical images as an aid during use by diagnostic radiology, oncology, radiation therapy planning and other medical specialties.

    Reason

    An anomaly was detected such that, under certain conditions, a summed dose created by Velocity replaces the calculated dose from an approved plan in Eclipse when importing the dose from Velocity.

    Action

    Velocity Medical Solutions sent a Urgent Field Safety Notice dated July 25th, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Velocity advises customers creating Dose volumes in Velocity to refrain from exporting these dose files to Eclipse until the customers install has been upgraded to Velocity 3.0.1, which will be available August 5th, 2013. A new version of Velocity that corrects this error, Velocity v3.0.1, will be available on August 5th, 2013 for upgrade at no cost. Please contact your Velocity Medical representative to obtain this upgrade. Service representative will upgrade the application at your earliest convenience. Please advise the appropriate personnel working in your medical department of the content of this letter. We sincerely apologize for any inconvenience and thank you in advance for your co-operation. Contact Information. Helpdesk: (404) 920-1966 or (855) 857-0802 and press 2.

    Distribution

    Worldwide Distribution - US (nationwide) including the states of AL, CA, CO, CT, DC, FL, GA, IL, IN, LA, MA, MD, MI, MS, NC, NY, PA, SC, TN, TX, WI, and the countries of Belarus, Italy and Switzerland.

    Quantity

    54 installs