Events

Retiro De Equipo (Recall) de Device Recall syngo RT Therapist and syngo RT Therapist

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
    60461
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0462-2012
  • Fecha de inicio del evento
    2011-11-02
  • Fecha de publicación del evento
    2012-01-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105463
  • 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
    Accelerator, linear, medical - Product Code IYE
  • Causa
    The software release will bring current installed base system to the forward production version. it is a result of the final system testing addressing several safety issues that are not critical for the safe use of the device and multiple performance defects.
  • Acción
    Siemens sent Customer Information letters and Update Instructions TH024/11/S for the installation of software release 4.2.108 beginning on November 2, 2011 to all affected consignees. Sites with active devices for the Oncology system were sent the current Update Instructions TH014/11/S for the installation of software release 4.2.108 and Customer Information letter beginning November 22, 2011. Consignees were asked to include the Customer Information in their syngo RT Oncologist System Owner Manual chapter "Safety Advisory Letters" where it should remain. For questions regarding this recall call 925-602-8157.

Device

Device Recall syngo RT Therapist and syngo RT Therapist
  • Modelo / Serial
    Part number 08162815 - syngo RT Therapist Part number 08168754 - syngo RT Therapist Connect/MOSAIQ OIS. Part number 10652131 - syngo RT Oncologist Part number 10658604 - syngo Suite for Oncology System.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worlwide Distribution - USA (nationwide) including UT, OH, TN, FL, WI, IN, KY, CA, PA, SD, NY and the countries of India, Germany, United Kingdom, Australia, Poland, Japan, Croatia, India, Columbia, Belgium, Puerto Rico, China, Sweden, South Africa and Czech Republic.
  • Descripción del producto
    syngo RT Therapist and syngo RT Therapist Connect/MOSAIQ OIS. || This correction applies to customers who use the syngo RT Therapist v4.2 or the combination of syngo RT Therapist v4.2 with syngo RT Oncologist v4.2 from Siemens. || 12/7/2011: Update: Syngo RTT4.2.108 SW contains the same SW content when installed on the syngo Oncologist Workspace (license key controlled). Currently the syngo Oncologist SW version is 4.2.92 P04. By installing this update, the Oncologist will match the RTT version 4.2.108. || The intended use of the Siemens branded Artiste, Oncor and Primus family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Dirección del fabricante
    Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord CA 94520-1200
  • Source
    USFDA