Events

Recall of ACUSON X700 Ultrasound System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Medical Solutions USA, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    73886
  • Event Risk Class
    Class 2
  • Event Number
    Z-1572-2016
  • Event Initiated Date
    2015-09-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-04-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145322
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, imaging, pulsed doppler, ultrasonic - Product Code IYN
  • 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.
  • Action
    September 5, 2015 we initiated a correction via update program US020/15/S where we visited all four units and updated their software to version 1.0.05

Device

ACUSON X700 Ultrasound System
  • Model / Serial
    Material (System) IVK Group Serial number: 10658844 ACUSON X700 356559 10658844 ACUSON X700 356733 10658844 ACUSON X700 356734 10658844 ACUSON X700 358714
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in Germany, U.A.E., Hungary and Brazil.
  • Product 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.
  • Manufacturer
    Siemens Medical Solutions USA, Inc.

Manufacturer

Siemens Medical Solutions USA, Inc.
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc., 685 E Middlefield Rd, Mountain View CA 94043-4045
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA