Retiro De Equipo (Recall) de Device Recall AlignRT

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 Vision Rt 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
    Accelerator, linear, medical - Product Code IYE
  • Causa
    Potential use error when the external gate controller is turned on after the vision rt software has been opened.
  • Acción
    VisionRT sent an Urgent Medical Device Correction Notification letter dated November 10, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers shall: A. Print the instructions in Appendix 3, place them in the front of the product guide and ensure these instructions are read and understood by all those who need to be aware of them within their organisation; B. Maintain awareness of this issue until all actions indicated in this letter have been successfully completed; C. Promptly inform Vision RT if they believe that patient harm occurred due to this issue; AND D. Complete the acknowledgement in Appendix 1 and return it via email to Contact Vision RT Should you have any queries on this letter, please do not hesitate to contact Vision RT by telephone on +44 20 83464300 (866 778-2379 from the US) or as per For questions regarding this recall call 866-594-5443.


  • Modelo / Serial
    Serial numbers (internally referred to as PCR numbers):   USA: 247-018, 247-039, 247-040, 247-053, 247-060, 247-061 , 247-062, 247-063, 247-068, 247-071 , 247-075, 247-076 , 247-078, 247-081, 247-083, 247-096, 247-099, 247-100,, 247-101, 247-102 , 247-110 , 247-118, 247-119, 247-122, 247-124, 247-127, 247-129, 247-130, 247-138, 247-140, 247-142, 247-149, 247-150, 247-153, 247-161, 247-167, 247-171, 247-184, 247-194, 247-200, 247-207, 247-212, 247-213, 248-012, 248-018, 248-041  Rest of the world:  247-035, 247-073, 247-114, 247-131, 247-147, 247-148, 247-188
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment.
  • Manufacturer


  • Dirección del fabricante
    Vision Rt Inc, 8840 Stanford Blvd, Columbia MD 21045-5827
  • Source