Events

Retiro De Equipo (Recall) de Device Recall ACUSON SC2000 Ultrasound System

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
    71122
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1584-2015
  • Fecha de inicio del evento
    2012-07-11
  • Fecha de publicación del evento
    2015-05-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-05-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136167
  • 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
    In certain situations, loss of post exercise images can occur in stress echo.
  • Acción
    On 07/11/2012 a field corrective action was initiated via update programs US016/12/P to update all affected SC2000 customers to software version VA20C, which contains the fix to the described issue. Each customer received a site visit to install the software update.

Device

Device Recall ACUSON SC2000 Ultrasound System
  • Modelo / Serial
    Serial Numbers: 400935 400140 400532 400580 400582 400592 400597 400635 400643 400652 400685 400686 400733 400737 400746 400752 400753 400771 400777 400784 400833 400919 400499 400896 400809 400296 400111 400319 400793 400699 400849 400816 400213 400212 400215 400251 400254 400407 400560 400670 400713 400722 400729 400730 400731 400734 400764 400766 400815 400920 400945 400149 400289 400341 400444 400510 400547 400562 400575 400732 400779 400904 400936 400939 400980 400987 401009 400321 400549 400922 400125 400199 400200 400043 400755 400808 400926 400426 400756 400806 400950 400424 400566 400711 400727 400801 400834 400911 400927 400933 400827 400127 400637 400642 400205 400880 400690 400745 400778 400802 400240 400591 400432 400780 400785 400819 400824 400825 400826 400838 400842 400844 400845 400863 400869 400871 400910 400937 400938 400724 400846 400973 400219 400300 400158 400159 400172 400181 400182 400187 400191 400192 400211 400249 400250 400279 400298 400301 400339 400512 400544 400579 400588 400590 400688 400738 400739 400741 400798 400812 400761 400837 400841 400850 400655 400839 400870 400879 400917 400578 400278 400423 400563 400606 400769 400901 400116 400165 400178 400214 400262 400266 400274 400275 400271 400414 400420 400430 400616 400760 400823 400876 400915 400928 400934 400253 400403 400412 400498 400581 400728 400765 400189 400897 400924 400908 400796 400836 400840 400946 400948 400957 400963 400218 400277 400856
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- US and Albania, Australia, Austria, Bangladesh, Bulgaria, Canada, Colombia, Denmark, Ecuador, Egypt, France, Germany, Hungary, Iceland, India, Israel, Italy, Japan, Kenya, Kuwait, Malaysia, Mauritius, Mexico, Netherlands, P.R. China, Philippines, Portugal, Rep. of Yemen, Republic Korea, Russian Fed., San Marino, Saudi Arabia, Singapore, Spain, Suriname, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E., United Kingdom, and Venezuela.
  • Descripción del producto
    ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B. Model number 10433816. || The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications.
  • Manufacturer
    Siemens Medical Solutions USA, Inc.

Manufacturer

Siemens Medical Solutions USA, Inc.
  • Dirección del fabricante
    Siemens Medical Solutions USA, Inc., 685 E Middlefield Rd, Mountain View CA 94043-4045
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA