BEUDAMED
    FDA Recall Terminated

    The BladderScan BVI 9400 is a portable ultrasound instrument that provides a noninvasive measurement of urinary bladder volume. The device consists of an ultrasound probe that scans the patient's bladder, and a battery operated console that provides measurement related information. The BVI 9400 measures ultrasonic reflections on multiple planes inside the body and produces a three dimensional image. Based on the image, the BVI 9400 calculates and displays bladder volume.

    Recall: Z-1939-2009 · Initiated May 18, 2009

    Recall

    Recall Number
    Z-1939-2009
    Event Number
    52769
    Firm
    Verathon, Inc.
    FEI Number
    3022472
    Product Code
    IYO
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 18, 2009
    Posted
    September 17, 2009
    Terminated
    October 7, 2010
    Address
    20001 N Creek Pkwy, Bothell, WA, 98011-8218

    Description

    The BladderScan BVI 9400 is a portable ultrasound instrument that provides a noninvasive measurement of urinary bladder volume. The device consists of an ultrasound probe that scans the patient's bladder, and a battery operated console that provides measurement related information. The BVI 9400 measures ultrasonic reflections on multiple planes inside the body and produces a three dimensional image. Based on the image, the BVI 9400 calculates and displays bladder volume.

    Reason

    Three specific issues are being addressed: 1. Calculation and use of an incorrect year in dates after 12/31/2009. 2. Double scans, continuous scans, and double printing. 3. Calibration sensitivity.

    Action

    U.S. customers (including Government) were sent a post card on or about 5/18/2009 and were called about the upgrade. Units are to be upgraded by the customers using an online tool called ScanPoint. Customers may elect to return their units to the firm for upgrading. Canadian customers were phoned by Verathon. For foreign units sold and distributed through one of the recalling firm's related firms, Service Bulletin SB-0014 was sent to the distributors located in The Netherlands, United Kingdom, and Australia. Contact Verathon Customer Care at 1-800-331-2313 if you have any questions.

    Distribution

    Worldwide - US, Canada, Malaysia, Hong Kong, Singapore, Argentina, New Zealand, Barbados, Dominican Republic, and Costa Rica.

    Quantity

    1,978