BEUDAMED
    FDA Recall Terminated

    ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL.

    Recall: Z-1200-2018 · Initiated March 5, 2018

    Recall

    Recall Number
    Z-1200-2018
    Event Number
    79568
    Firm
    Siemens Medical Solutions USA, Inc.
    FEI Number
    2936884
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 5, 2018
    Posted
    March 26, 2018
    Terminated
    February 26, 2021
    Address
    685 E Middlefield Rd, Mountain View, CA, 94043-4045

    Description

    ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL.

    Reason

    The ECG signal may flatline due to electromagnetic interference during the use of electrosurgical equipment.

    Action

    Undated recall letters were issued via email (if they had an email address for the customer) or via certified mail (if no email address was available) on 3/5/2018.

    Distribution

    Distribution was made to medical facilities in AZ, CA, CT, FL, IL, IN, KS, KY, MI, MN, MO, NJ, NY, NC, OH, PA, TX, VA, and WA. There was no military/government distribution. Foreign distribution was made to Argentina, Australia, Austria, Belgium, Bosnia Herzeg, Colombia, Croatia, Denmark, France, Germany, India, Ireland, Israel, Italy, Japan, Mexico, New Zealand, Philippines, Poland, Republic Korea, Romania, Singapore, Slovakia, Spain, Sweden, Taiwan, Thailand, Turkey, UAE, and Vietnam.

    Quantity

    229 systems