Events

Retiro De Equipo (Recall) de Symbia S Series SPECT 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
    60142
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0283-2012
  • Fecha de inicio del evento
    2011-10-14
  • Fecha de publicación del evento
    2011-11-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-10-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104521
  • 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 and Computed Tomography - Product Code KPS
  • Causa
    Errors could potentially impact image interpretation. the acquisition software is exhibiting a defect in the energy window position when an isotope is peaked. there is a potential patient safety issue when running syngo mi applications version va60a with foresight detectors firmware version v1.5.9.12 on the symbia systems.
  • Acción
    Siemens Medical Solutions USA, Inc. sent an "Urgent Field Correction Recall" letter dated October 14, 2011 to all affected customers. The letters informed customers of the acquisition software defect in the energy window position when an isotope is peaked, which could potentially impact image interpretation, and that the AEB firmware version on their imaging system has been changed to a previously released version until acquisition software service pack is available. For questions or assistance they were instructed to contact Siemens Medical Solutions USA, Inc. at (800) 888-7436.

Device

Symbia S Series SPECT System
  • Modelo / Serial
    Symbia S Series systems, serial numbers 1236 and 1555, both with syngo MI Applications version VA60A and Foresight Detector AEB firmware version v1.5.9.12
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Florida, Illinois and Texas
  • Descripción del producto
    Siemens Medical Solutions USA, Inc., Symbia S Series SPECT System; Single-Photon Emission Computed Tomography. Indications for use: SPECT + CT: Perform scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy.
  • 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