BEUDAMED
    FDA Recall Terminated

    MicroMaxx ultrasound system and M-Turbo ultrasound system is Medical Diagnostic Ultrasound. General purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body.

    Recall: Z-0057-2012 · Initiated July 18, 2011

    Recall

    Recall Number
    Z-0057-2012
    Event Number
    59442
    Firm
    Sonosite, Inc.
    FEI Number
    3002087856
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 18, 2011
    Posted
    October 18, 2011
    Terminated
    September 14, 2012
    Address
    21919 30th Dr SE, Bothell, WA, 98021-3904

    Description

    MicroMaxx ultrasound system and M-Turbo ultrasound system is Medical Diagnostic Ultrasound. General purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body.

    Reason

    This is a software anomaly. In some circumstances, if the Systolic/Diastolic (S/D) ratio value is interpreted directly from the display, the clinician could potentially use an incorrect value of the S/D ratio in his/her assessment.

    Action

    The firm SonoSite, Inc., sent an "Urgent - Medical Device Correction" letter dated September 29, 2011 to its foreign and domestic customers. The letter described the product, problem, and actions to be taken. The customers were instructed to follow the three (3) steps provided in the letter to verify if the extended OB/GYN Calculations (EOBC) is enabled on their system. Additionally, SonoSite will perform a software upgrade to M-Turbo and/or MicroMax ultrasound system in order resolve the issue. The customers were instructed to contact Sonosite Technical Support via website: www.sonosite.com/sdratio; email: [email protected] (include contact information and address), or call in U.S. and Canada: 1-877-590-4982. If you have any questions or concerns regarding this matter, do not hesitate to contact in US and Canada at 1-877-657-8118, Monday-Friday, 6 am-5 pm PST. Customer can also send an email to Technical Support at [email protected]

    Distribution

    Worldwide distribution: USA (nationwide) including Puerto Rico; and countries of: Afghanistan, Algeria, American Samoa, Argentina, Australia, Bolivia, Botswana, Brazil, Canada, China, Costa Rica, Cyprus, Dominican Republic, Estonia, France, Gambia, Germany, Great Britain, Guam, Guatemala, Honduras, Hong Kong, Hungary, India, Iran, Ireland, Italy, Japan, Jordan, Kenya, Korea, Kuwait, Mauritius, Mexico, Netherlands, New Zealand, Nigeria, Northern Mariana Islands, Oman, Panama, Paraguay, Peru, Philippines, Portugal, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, Tanzania, Uganda, United Arab Emirates, Viet Nam, and Zambia.

    Quantity

    4236 units (US) and 4089 units (internationally)