Events

Retiro De Equipo (Recall) de Device Recall Symbia Radiation Therapy Pallet

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
    58918
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2980-2011
  • Fecha de inicio del evento
    2011-06-22
  • Fecha de publicación del evento
    2011-08-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-11-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100609
  • 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
    Pallet for Radiation Computed Tomography (CT), Radiation Therapy - Product Code KPS
  • Causa
    There a potential patient safety issue when using the symbia radiation therapy pallet. when a patient is not iso-centered before starting a scan with the symbia t series systems and a non-circular orbit is selected, it is possible that one of the detectors may come into contact with the patient.
  • Acción
    Siemens Medical Solutions USA, Inc. sent an "Urgent Field Correction Recall" letter dated June 06, 2011 to all affected customers. The letter informs customers of the potential safety issue if the patient is not iso-centered before starting a scan and a non-circular orbit is selected and provided recommendations including ensure the patient is iso-centered before starting a scan. If the patient cannot be positioned at the iso-center of the RTP, instructions were provided. The customers are asked to complete the Mandatory Fax-Back Form acknowledging receipt and understanding of the letter. For questions or assistance contact Siemens Medical Solutions USA, Inc. at (800) 888-7436 (USA).

Device

Device Recall Symbia Radiation Therapy Pallet
  • Modelo / Serial
    material number 10412621, serial numbers 1023, 1045, 1052, 1067, 1073, 1076, 1083, 1110, 1116, 1118, 1136, 1137, 1141, 1146, 1154, 1155, 1167 and 1241
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: Nationwide (USA) including the states of Florida and Texas; and the countries of Canada, China, Italy, Mexico, Poland, Portugal and Russia.
  • Descripción del producto
    Symbia Radiation Therapy Pallet. || Siemens Medical Solutions USA, Inc. || An accessory to the Symbia T Series Emission Computed Tomography System/X-Ray Computed Tomography System.This specialty pallet is used for performing SPECT and/or SPECT/CT Scans on oncology patients with the goal of fusing the SPECT and/or SPECT/CT data with CT simulation data for planning radiation therapy. The pallet attaches to the patient beds carbon fiber pallet.
  • 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