Retiro De Equipo (Recall) de Siemens

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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • 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
    Medical Charged-Particle Radiation Therapy System - Product Code IYE
  • Causa
    Software. the firm issued an advisory letter update instruction th030/07/s as a result of a complaint that images viewed in the device may shift, which could result in mistreatment. the advisory alerts all its affected customers of the image issue to prevent potential mistreatment.
  • Acción
    Customer Safety Advisory Notice was issued on 10/03/2007 to consignees, via certified mail. Consignees are strongly cautioned that they should not further correct the image alignment at this time as doing so will result in incorrect offset values which could lead to incorrect repositioning of the patient. Consignees are instructed to check the "Filter Images on Loading" and "Saving of Filtered Images" config settings, and apply any additional filters to the image BEFORE using the interactive shift or landmark registration tools. Do not correct any perceived issues. A software fix is being validated and will be available soon.


  • Modelo / Serial
    Software Numbers 7358299, 7360857, and 8141835. Applies only to those parts used with the following devices: Coherence AG Therapist-5863506; Coherence Therapist System-7333680; Coherence Impression Therapist-7341410; PRIMEVIEW 3i-7341428; AG Therapist 3rd party V&R-7351898; Coherence Therapist 2.0-8139839 and PRIMEVIEW 3i 2.0-8139847.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Class II Recall - Worldwide Distribution --- including USA and countries of Angola, Australia, Brazil, Canada, Croatia, Denmark, Egypt, France, Germany, Greece, Hungary, India, Iran, Italy, Japan, Malaysia, Netherlands, New Zealand, P.R. China, Poland, Portugal, Republic Korea, Russian, Fed. Saudi Arabia, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Thailand, Trinidad, Tobago, Turkey, United States, Vietnam.
  • Descripción del producto
    Medical charged-particle radiation therapy system. Siemens Linear Medical Accelerators equipped with COHERENCE Therapist R2.0 and Oncologist R2.0. Product update, TH 030//07/S. The COHERENCE Therapist R2.0 software numbers are: 7358299, 7360857, and 8141835 and applies only to those parts used with the following devices: Coherence AG Therapist; Coherence Therapist System; Coherence Impression Therapist; PRIMEVIEW 3i; AG Therapist 3rd party V&R; Coherence Therapist 2.0 and PRIMEVIEW 3i 2.0.
  • Manufacturer


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