Events

Retiro De Equipo (Recall) de Device Recall ARTISTE or ONCOR Digital Linear Accelerators with 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
    62519
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2073-2012
  • Fecha de inicio del evento
    2012-06-25
  • Fecha de publicación del evento
    2012-07-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-10-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110823
  • 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
    Potential safety issue when using the immediate resumption feature after a control console interlock during the delivery of flattening-filter-free (multiple-x) beams or segments. in a very rare scenario, the rt therapist will send again the previously completed beam or segment for delivery to the control console, thus repeating the already delivered monitor units of the same beam or segment.
  • Acción
    The firm issued "Urgent: Medical Device Correction" letters delivered by the Siemens Customer Service Group or by certified mail to all its direct consignees, informing them of the affected product and providing instructions on the recall. The firm stated that release of this UI TH018/12/S to distribute the notifications began on June 25, 2012.

Device

Device Recall ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist
  • Modelo / Serial
    ARTISTE, Part #: 08139789, ONCOR Avant Garde, Part #: 05863472, ONCOR Impression Plus, Part #: 05857912, ONCOR Expression, Part #: 07360717
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution, including the state of Florida (USA) and the countries of Germany, India, Poland, Thailand, and the Republic of Korea.
  • Descripción del producto
    ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist version 4.2/MOSAIQ OIS Systems and Multiple-X, Manufactured by SIEMENS AG. The ARTISTE and ONCOR family of Linear Accelerators are used 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