BEUDAMED
    FDA Enforcement Class II Terminated

    ACUSON X700 Ultrasound System with software version 1.0.04. Model numbers: 10658844  ACUSON X700 Ultrasound System 10658846 - ACUSON X700 Ultrasound System (Russia) 10658845 - ACUSON X700 Ultrasound System (Korea) Radiology: The Siemens ACUSON X700 ultrasound imaging system is intended for the following applications: Cardiac (Adult, Pediatric), Transesphageal (Cardiac), Intracardiac, Cerebrovascular, Peripheral Vessel, Abdominal, Renal, Fetal, Abdominal, Intra-operative, Pediatric, Small Organ, Neonatal Cepahalic, Adult Cephalic, Orthopedics, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Pelvic, Obstetrical, Gynecological and Urological applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

    Recall: Z-1572-2016 · Reported May 4, 2016

    Enforcement

    Recall Number
    Z-1572-2016
    Event ID
    73886
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    May 4, 2016
    Initiation Date
    September 5, 2015
    Classification Date
    April 27, 2016
    Termination Date
    April 27, 2016
    Address
    685 E Middlefield Rd, N/A, Mountain View, CA, 94043-4045, United States

    Description

    ACUSON X700 Ultrasound System with software version 1.0.04. Model numbers: 10658844  ACUSON X700 Ultrasound System 10658846 - ACUSON X700 Ultrasound System (Russia) 10658845 - ACUSON X700 Ultrasound System (Korea) Radiology: The Siemens ACUSON X700 ultrasound imaging system is intended for the following applications: Cardiac (Adult, Pediatric), Transesphageal (Cardiac), Intracardiac, Cerebrovascular, Peripheral Vessel, Abdominal, Renal, Fetal, Abdominal, Intra-operative, Pediatric, Small Organ, Neonatal Cepahalic, Adult Cephalic, Orthopedics, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Pelvic, Obstetrical, Gynecological and Urological applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

    Reason

    Due to a communication error between the software and V5Ms transducers rotation function, ACUSON X700 ultrasound systems at software versions 1.1.04, display an IMG_15 error message causes the system to lock up, which requires a reboot to recover system operation.

    Code Info

    Material (System) IVK Group Serial number: 10658844 ACUSON X700 356559 10658844 ACUSON X700 356733 10658844 ACUSON X700 356734 10658844 ACUSON X700 358714

    Distribution

    Distributed in Germany, U.A.E., Hungary and Brazil.

    Quantity

    4