BEUDAMED
    FDA Recall Terminated

    ACUSON SC2000 Power Input: 100-240VAC, 1600 Max 50/60Hz; Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mountain View, CA 94043 Ultrasound imaging system.

    Recall: Z-0825-2014 · Initiated December 22, 2013

    Recall

    Recall Number
    Z-0825-2014
    Event Number
    67226
    Firm
    Siemens Medical Solutions USA, Inc.
    FEI Number
    2936884
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 22, 2013
    Posted
    January 24, 2014
    Terminated
    March 5, 2015
    Address
    685 E Middlefield Rd, Mountain View, CA, 94043-4045

    Description

    ACUSON SC2000 Power Input: 100-240VAC, 1600 Max 50/60Hz; Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mountain View, CA 94043 Ultrasound imaging system.

    Reason

    The locking mechanism that is intended to hold the control panel in a fixed position can become loose and fail to lock the rotation of the control panel, making it unable to steer or control during transport.

    Action

    Customer Safety Advisory Letters were sent to all affected users on December 22, 2013. Letters advised of the issues and the actions they should take until a Siemens Field Engineer will visit and upgrade the control panel.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Australia, Austria, Canada, Ecuador, Finland, France, Germany, India, Ireland, Israel, Italy, Japan, Mexico, P.R. China, Philippines, Portugal, Republic Korea, Russian Fed. Saudi Arabia, Serbia, South Africa, Spain, Suriname, Sweden, Taiwan, Turkey, U.A.E., and United Kingdom.

    Quantity

    271 units