BEUDAMED
    FDA Recall Terminated

    ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35) and using Stress Echo Feature. Ultrasound imaging system.

    Recall: Z-1668-2014 · Initiated April 23, 2014

    Recall

    Recall Number
    Z-1668-2014
    Event Number
    68197
    Firm
    Siemens Medical Solutions USA, Inc.
    FEI Number
    2936884
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 23, 2014
    Posted
    May 28, 2014
    Terminated
    November 12, 2015
    Address
    685 E Middlefield Rd, Mountain View, CA, 94043-4045

    Description

    ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35) and using Stress Echo Feature. Ultrasound imaging system.

    Reason

    Potential malfunction due to a software issue for ACUSON SC2000 ultrasound systems using software version 3.5 (VA35) when using the stress echo feature which could cause the need for the study to be repeated.

    Action

    Siemens sent a Consumer Safety Advisory Notification letter on April 23, 2014, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the stress echo feature with software version .5. For studies acquired with systolic-only captures: review all patient studies on exams performed after software revision 3.5 was installed on your system. If you are unsure when this software was installed on your system, please contact your local Customer Service representative. Foreign distributors will implement distribution of the field correction to their customers. For questions regarding this recall call 650-694-5398.

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belarus, Dominican Rep., France, Germany, India, Indonesia, Israel, Japan, Mexico, New Zealand, Norway, Philippines, Poland, Republic of Korea, Romania, Russian Fed., Saudi Arabia, Singapore, Sweden, Switzerland, Turkey, U.A.E., Ukraine, and United Kingdom.

    Quantity

    177 units