BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1200-2018 · Reported May 16, 2018

    Enforcement

    Recall Number
    Z-1200-2018
    Event ID
    79568
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 16, 2018
    Initiation Date
    March 5, 2018
    Classification Date
    May 7, 2018
    Termination Date
    February 26, 2021
    Address
    685 E Middlefield Rd, N/A, Mountain View, CA, 94043-4045, United States

    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.

    Code Info

    Software versions VB20A, VB20B, or VB20C that have a common physio module (CPM) (known by customers as the ECG (physio) hardware) installed at revision 4

    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