BEUDAMED
    FDA Recall Terminated

    Vital Connect 4.0 & 4.1, radiological image processing software A Medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital images acquired from a variety of imaging devices including: CT MR, CR/DR/DX, SC, US, NM, PET, XA and RF, etc. Vital connect has the following intended use: Vessel Probe is intended for viewing the anatomy and pathology of a patient's coronary arteries. Clinicians select any artery to view the following anatomical references: the highlighted vessel in 3D, two rotate-able curved MPR vessel views displayed at angles orthogonal to each other, and cross sections of the vessel.

    Recall: Z-1021-2011 · Initiated August 23, 2010

    Recall

    Recall Number
    Z-1021-2011
    Event Number
    56923
    Firm
    Vital Images, Inc.
    FEI Number
    3001654007
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    August 23, 2010
    Posted
    February 2, 2011
    Terminated
    November 6, 2012
    Address
    5850 Opus Parkway, Suite 300, Plymouth, MN, 55343-4414

    Description

    Vital Connect 4.0 & 4.1, radiological image processing software A Medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital images acquired from a variety of imaging devices including: CT MR, CR/DR/DX, SC, US, NM, PET, XA and RF, etc. Vital connect has the following intended use: Vessel Probe is intended for viewing the anatomy and pathology of a patient's coronary arteries. Clinicians select any artery to view the following anatomical references: the highlighted vessel in 3D, two rotate-able curved MPR vessel views displayed at angles orthogonal to each other, and cross sections of the vessel.

    Reason

    There is a potential alignment error of fused PET/CT images in the Vitrea Core component of Vitrea Enterprise Suite 1.2 and 1.3. The error occurs during panning of the fused PET/CT images. Because the PET data has a larger voxel size than the CT data, it is possible to pan the CT image in more frequent, smaller steps than the PET image, so that the fused PET image does not move until the CT data

    Action

    The firm, Vital Images, Inc,., sent a "Urgent Software Alert" letter dated August 23, 2010 to all customers. The letter described the product, problem and actions to be taken by the customers. The customers were instructed to not use the PET/CT fusion functionality until the software updates are provided and to re-examine any past results. If you have any questions or comments, contact Customer Support at [email protected] or at 1-800-208-3005.

    Distribution

    Worldwide Distribution: USA including states of: AK, AZ, CA, CO, CT, FL, GA, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MS, MO, NH, NJ, NM, NY, NC, ND, OH, PA, SC, TN, TX VA, WV, WI, and WY; and countries of: AUSTRALIA, HONG KONG, UNITED KINGDOM, NETHERLANDS, FRANCE, BELGIUM, CANADA, CHINA, AUSTRALIA, SWITZERLAND, and ITALY.AUSTRALIA, HONG KONG, UNITED KINGDOM, NETHERLANDS, FRANCE, BELGIUM, CANADA, CHINA, AUSTRALIA, SWITZERLAND, ITALY.

    Quantity

    178