Events

Retiro De Equipo (Recall) de ARIA Radiation Oncology Version 11

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 Varian Medical Systems, Inc. Oncology Systems.

¿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
    63471
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0187-2013
  • Fecha de publicación del evento
    2012-11-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-12-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113951
  • 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
    An anomaly has been identified with the aria oncology information system version 11 where monitor units of one fraction may be incorrect, when partial treatment is being continued.
  • Acción
    "Urgent Medical Device Correction/ Urgent Field Safety Notice" letters were sent on September 24, 2012 by Certified Mail with return receipt to all affected users. The problem was described and recommended user actions were provided. The notification letters were to also be distributed to Varian Sales, Marketing, and Service organizations. US customers may contact the Varian help desk at 1-(888) 827-4265.

Device

ARIA Radiation Oncology Version 11
  • Modelo / Serial
    Model number: HIT Serial numbers: HIT0027 HIT1430R3 HIT2208R3 HIT3513 HIT2546 HIT2546 HIT2546 HIT0028 HIT1470M HIT2208R4 HIT3679 HIT2591 HIT2591 HIT2591 HIT0032 HIT1470R1 HIT2208R5 HIT3910 HIT2615 HIT2615 HIT2615 HIT0134 HIT1470R2 HIT2212 HIT3927M HIT2643 HIT2643 HIT2643 HIT0155 HIT1523M HIT2237M HIT3927R1 HIT2645 HIT2645 HIT2645 HIT0170M H1T1523R1 HIT2237R1 HIT3927R2 HIT2834 HIT2834 HIT2834 HIT0170R1 HIT1587M HIT2267M HIT3967 HIT2865 HIT2865 HIT2865 HIT0170R2 HIT1587R1 HIT2267R1 HIT4014 HIT2894M HIT2894M HIT2894M HIT0170R3 HIT1587R2 HIT2275M HIT4116 HIT2894R1 HIT2894R1 HIT2894R1 HIT0182 HIT1587R3 HIT2275R1 HIT4118M HIT2894R2 HIT2894R2 HIT2894R2 HIT0183 HIT1587R4 HIT2275R2 HIT4118R1 HIT2894R3 HIT2894R3 HIT2894R3 HIT0191M HIT1589M HIT2275R3 HIT4381 HIT2943 HIT2943 HIT2943 HIT0191R1 HITI589R2 HIT2275R4 HIT4555 HIT2953 HIT2953 HIT2953 HIT0191R2 HITI589R3 HIT2291M HIT4592 HIT2997 HIT2997 HIT2997 HIT0227 HIT1589R4 HIT2291R1 HIT4627 HIT3088M HIT3088M HIT3088M HIT0339M HIT1589R5 HIT2291R2 HIT4861 HIT3088R1 HIT3088R1 HIT3088R1 H1T0339R1 HIT1589R6 HIT2291R3 HIT4884 HIT3088R2 HIT3088R2 HIT3088R2 HIT0342 HIT1589R7 HIT2291R4 HIT4888M HIT3088R3 HIT3088R3 HIT3088R3 HIT0397 HIT1589R8 HIT2291R5 HIT4888R1 HIT3088R4 HIT3088R4 HIT3088R4 HIT0432M HIT1589R9 HIT2291R6 HIT4888R2 HIT3088R5 HIT3088R5 HIT3088R5 HIT0432R1 HIT1660M HIT2293 HIT4888R3 HIT3088R6 HIT3088R6 HIT3088R6 HIT0432R2 HIT1660R2 HIT2346M HIT4894 HIT3097 HIT3097 HIT3097 HIT0468M HIT1660R3 HIT2346R1 HIT4896 HIT3165 HIT3165 HIT3165 HIT0468R1 HIT1671 H1T2425 HIT4903 HIT3206 HIT3206 HIT3206 HIT0535 HIT1693 HIT2441 HIT4906 HIT3267 HIT3267 HIT3267 HIT0551 HIT1726 HIT2477M HIT4932M HIT1800 HIT2522 HIT0632M HIT1753 HIT2477R1 HIT4932R1 HIT0632R1 HIT1757 HIT2477R2 HIT4947 HIT0632R2 HIT1767M HIT2477R3 HIT4974 HIT0668 HIT1767R1 HIT2512M HIT4982 HIT0691M HIT1780 HIT2512R1 HIT5061 HIT0691R1 HIT2208R2 HIT3268 HIT0691R2.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - Nationwide(USA) and including the countries of Australia, Denmark and the United Kingdom.
  • Descripción del producto
    ARIA Radiation Oncology, Version 11. Varian Medical Systems, Palo Alto, CA. The ARIA Radiation Oncology product is a treatment plan and image management application.
  • Manufacturer
    Varian Medical Systems, Inc. Oncology Systems

Manufacturer

Varian Medical Systems, Inc. Oncology Systems
  • Dirección del fabricante
    Varian Medical Systems, Inc. Oncology Systems, 911 Hansen Way, Palo Alto CA 94304-1028
  • Empresa matriz del fabricante (2017)
    Varian Medical Systems Inc
  • Source
    USFDA