BEUDAMED
    FDA Recall Terminated

    Voiceware clip software update to certain Horizon Medical Imaging Systems. McKesson Medical Imaging Company. Richmond, Canada V6X 3G5. Intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video and associated medical information from various medical imaging systems.

    Recall: Z-1735-2010 · Initiated May 7, 2010

    Recall

    Recall Number
    Z-1735-2010
    Event Number
    55723
    Firm
    Mckesson Medical Immaging Suite 130-10711 Cambie Road Richmond Canada British Columbia
    FEI Number
    3003757840
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 7, 2010
    Posted
    May 28, 2010
    Terminated
    August 15, 2012

    Description

    Voiceware clip software update to certain Horizon Medical Imaging Systems. McKesson Medical Imaging Company. Richmond, Canada V6X 3G5. Intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video and associated medical information from various medical imaging systems.

    Reason

    Voice Clip issue: When the user is recording voice clips in Horizon Rad Station, there is a potential for voice clips to be saved to the incorrect study of the same patient.

    Action

    McKesson Medical Imaging Company issued an "Advisory Notice" dated May 7, 2010. Consignees were notified of the affected product and advised to contact McKesson Customer Support department to review their sites current configuration and install the appropriate product software update(s). For further information, contact McKesson Medical Imaging Customer Support at 1-800-663-2533. On June 19, 2010 the recall was amended to include the following actions to follow: Instead of highlighting the anchor study in the Patient Portfolio Sidebar before saving t he voice clip in the Patient Portfolio Sidebar, McKesson recommends that you save the voice clip to the desired study first, before browsing through other documents. A software update that prevents the problem from occurring is currently under development for all affected releases and will be available in approximately three months. Consignees will be notified when the software update is ready to be installed on their system.

    Distribution

    Distributed Nationwide (AK, AL, AR, AZ, CA, CO, FL, GA, IN, IA, IL, KY, LA, MA, MD, MI, NC, ND, NE, NM, NY, NV, OH, OR, PA, RI, SC, TN, TX, WY, VA and WV) and Canada

    Quantity

    100 units