Retiro De Equipo (Recall) de Device Recall ARTISTE , ONCOR and PRIMUS digital accelerators with syngo RT Therapist v4.1 and 4.2 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
    58533
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2243-2011
  • Fecha de inicio del evento
    2011-03-31
  • Fecha de publicación del evento
    2011-05-23
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2012-03-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    Siemens found a potential safety issue related to patient treatment with table offsets on syngo rt therapist (rtt) 4.1 and 4.2 which could result in dose being delivered to wrong location.
  • Acción
    Siemens initiated an Urgent Medical Device Correction letter on March 31, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: use only relataive table setup with all planned table values '0' if applicable. In cases where the treatment plan contains at least one table parameter other than '0' to consider the following: Use only one PVG plus resulting offset per fraction. Once an offset has been applied do not use 'apply offset' at RTT for any further offset. Select the PVG and treatment beams in the same auto-sequence. In case this is not possible, the table position for each treatment beam, in the fraction, needs to be verified separately (especially for treatments with beams having different table posiitons. If an in-session resumption or individual download of beams has to be performed, make sure that the treatment table is in the correct position. In order to prevent any unintended table movement select manual table movement for all directions in the syngo RT Therapist service UI. Scenario 2 - Manual change of table posiiton followed by a PVG calculated offset. Always deliver the PVG's at the planned table position. Avoid manual change of table posiiton prior to applicaiton of PVG. Select the PVG and treatment beams in the same auto-sequence. In case this is not possible, the table position for each treatment beam, in the fraction, need to be verified separately (especially for treatments with beams having different table positions). If an in-session resumption or individual download of beams has to be performed, make sure that the treatment table is in the correct position. In order to prevent any unintended table movement select manual table movement for all directions in the syngo RT Therapist service UI. Customers were informed that a software update would be provided as soon as possible. Customers were asked to include the Customer Sa

Device

  • Modelo / Serial
    Therapist Express Basic Part number 08515289; syngo RT Therapist Part Number 08162815; syngo RT Therapist Connect / MOSAIQ OIS Part number 08168754.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including CA, DE, FL, KY, LA, MA, MI, MO, NC, NE, NJ, NY, OH, PA, SD, TN, UT, WI, and WV and the countries of Australia, Belgium, Canada, Croatia, Egypt, France, Germany, Hungary, India, Ireland, Italy, Japan, Malaysia, Netherlands, New Zealand, Norway, P.R. China, Philippines, Poland, Republic of Korea, Russian Federation, Saudi Arabia, South Africa, Spain, Turkey, and the United Kingdom.
  • Descripción del producto
    ARTISTE , ONCOR and PRIMUS digital accelerators with syngo RT Therapist v4.1 and 4.2 system; || Therapist Express Basic, syngo RT Therapist and syngo RT Therapist Connect/MOSAIQ OIS. || The ONCOR and PRIMUS may be updated to utilize the RTT v4.x software. || Distributed by Siemens, Healthcare, Concord, CA 94520 || Radiation therapy
  • Manufacturer

Manufacturer

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