Events

Retiro De Equipo (Recall) de Device Recall Symbia S Series SPECT System with a Pinhole Collimator

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
    37231
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0548-2007
  • Fecha de inicio del evento
    2007-01-30
  • Fecha de publicación del evento
    2007-02-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-11-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50151
  • 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
    Single-Photon Emission Computed Tomography - Product Code KPS
  • Causa
    Symbia systems, running on e.Soft version 5.5 or earlier, could allow a fully-extended patient pallet to come into contact with the pinhole collimator, resulting in system damage.
  • Acción
    Siemens sent Customer Safety Advisory Notice/Urgent Field Correction Recall letters dated 1/30/07 to all users of Symbia systems with a pinhole collimator and e.soft software versions 5.5 or earlier. The accounts were informed of the potential for a fully-extended patient pallet to come into contact with the pinhole collimator, resulting in system damage. The customers were advised that a Siemens Customer Service Representative would be sent to their site to upgrade their system software to version syngeo MI Applications 2006A within 30 days. The upgrade will be done free of charge.

Device

Device Recall Symbia S Series SPECT System with a Pinhole Collimator
  • Modelo / Serial
    All systems with pinhole collimators and e.soft software versions 5.5 or earlier: part number 08717741, serial numbers 01006, 01008, 01009, 01019, 01021, 01022, 01024, 01032, 01033, 01034, 01038, 01044, 01045, 01049, 01051, 01052
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution --- including USA states of Alabama, California, Georgia, Indiana, Kentucky, Michigan, Ohio, Pennsylvania, Texas, Virginia and countries of Australia, Bolivia, Canada, China, France, Germany, Hong Kong and Spain.
  • Descripción del producto
    Symbia S Series SPECT (Single-Photon Emission Computed Tomography) System with a Pinhole Collimator; Siemens Medical Solutions USA, Inc., Molecular Imaging, 2501 N. Barrington Road, Hoffman Estates, IL 60195-5203 USA; part number 08717741
  • Manufacturer
    Siemens Medical Solutions USA, Inc.

Manufacturer

Siemens Medical Solutions USA, Inc.
  • Dirección del fabricante
    Siemens Medical Solutions USA, Inc., 2501 Barrington Rd, Hoffman Estates IL 60195-2061
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA