Events

Retiro De Equipo (Recall) de Device Recall Acuson X300

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Siemens Medical Solutions USA, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    53209
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2065-2011
  • Fecha de inicio del evento
    2009-07-30
  • Fecha de publicación del evento
    2011-04-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-04-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84981
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    System, imaging, pulsed doppler, ultrasonic - Product Code IYN
  • Causa
    Software error with potential for misinterpretation of data-- the previous patient's last capture clip image can appear in the next patient's study.
  • Acción
    The firm, Siemens, sent a "CUSTOMER SAFETY ADVISORY NOTIFICATION" letter to its customers on July 30, 2009. The letter described the product, problem and actions to be taken. The customers were instructed they need to update any of the patient registration settings to reset the cine buffer so that no data is transferred between studies, if the system software is not being updated. Siemens informed the customers that a mandatory update software is being installed on their system free of charge. If you have any questions, contact (650) 969-9112.

Device

Device Recall Acuson X300
  • Modelo / Serial
    Serial numbers
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) and countries including: Albania, algeria, Argentina, Australia, Austria, Azerbaijan, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile,China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, India, Indonesia, Iran, Ireland, Italy, Japan, Kazakhstan, Kenya, Kosovo, Lativia, Lithuania, Luxembourg, New, Zealand, Nicaragua, Norway, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam.
  • Descripción del producto
    Acuson X300 systems at software versions 1.00.00 to 1.0.10 and 2.0.00 to 2.0.02, model numbers 10037409, 10132987, and 10038837, manufactured by Siemens Medical Solutions ultrasound business unit, Mountain View, CA || Medical device is an ultrasound imaging system for general radiology, fetal, abdominal, intraoperative, pediatric, small parts, neonatal/adult cephalic, cardiac, transesophageal, pelvic, transcranial, ob/gyn, urology, vascular, musculoskeletal, superficial musculoskeletal and peripheral vascular applications. The system also provides for measurements 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.
  • Dirección del fabricante
    Siemens Medical Solutions USA, Inc., 1230 Shorebird Way, P.O. Box 7393, Mountain View CA 94043
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA