BEUDAMED
    FDA Recall Terminated

    BVI 9600 Bladder Volume Instrument, Aorta Scan Mode The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements.

    Recall: Z-0003-2011 · Initiated August 23, 2010

    Recall

    Recall Number
    Z-0003-2011
    Event Number
    56411
    Firm
    Verathon, Inc.
    FEI Number
    3022472
    Product Code
    IYO
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    August 23, 2010
    Posted
    October 4, 2010
    Terminated
    September 8, 2011
    Address
    20001 N Creek Pkwy, Bothell, WA, 98011-8218

    Description

    BVI 9600 Bladder Volume Instrument, Aorta Scan Mode The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements.

    Reason

    The BladderScan BVI 9600 with AortaScan devices may experience the loss of a factory installed software configuration file which results in a loss of the aorta measurement function.

    Action

    Verathon sent an URGENT Medical Device Recall Notification letter dated August 12, 2010 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Verathon provided an addendum to the User Manual with instructions on how to reset the instrument. Customers were advised to: " Add the enclosed addendum to their current Users Manual. " Update the application software of the device to v2.7.0 or higher. If the customers had questions or needed support for the software update process, they were to contact Verathon Medical Customer Care at (425) 867-1348 or (800) 331-2313 or [email protected].

    Distribution

    Worldwide Distribution - USA and the countries of Australia, Canada, China, Colombia, European Union, United Kingdom, Saudi Arabia, and Singapore.

    Quantity

    351 units