Events

Retiro De Equipo (Recall) de Device Recall 4Z1c Transducer

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
    53211
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2149-2011
  • Fecha de inicio del evento
    2009-07-10
  • Fecha de publicación del evento
    2011-05-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-05-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84986
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Notas adicionales en la data
  • Causa
    Burn risk-- due to coolant leaks, patients may suffer burns or blisters due to increased temperature.
  • Acción
    A customer safety advisory notification was sent out to customers on 7/10/09, and a mandatory software update will also be conducted.

Device

Device Recall 4Z1c Transducer
  • Modelo / Serial
    seial numbers
  • Clasificación del producto
    Radiology Devices
  • Distribución
    Nationwide. Foreign: Japan, Italy, South Korea, Singapore, Yemen, Germany, Australia, and Greece.
  • Descripción del producto
    4Z1c Matrix Array Transducer, model number 10033682, used with ACUSON SC2000 ultrasound systems, model number 10433816, manufactured by Siemens Medical Solutions, Ultrasound Business Unit, Mountain View, CA. || The 4Z1c transducer is a special purpose ultrasound transducer designed to help clinicians perform adult echocardiography and pre-operative and intra-operative surgical assessments. Secondary applications include pediatric echocardiography, primarily benefiting older and larger pediatric populations, general abdominal and intra-operative pediatric abdominal imaging and peripheral vessel imaging.
  • 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