Events

Retiro De Equipo (Recall) de Device Recall Varian brand ARIA Radiation Oncology

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
    63713
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0531-2013
  • Fecha de inicio del evento
    2012-11-05
  • Fecha de publicación del evento
    2012-12-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-03-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114598
  • 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
    Varian medical systems has identified an anomaly with the aria oncology information system radiation oncology [aria ro] dicom import/export functionality where a 360 degree arc field may convert to static field during dicom export or import.
  • Acción
    Varian sent an Urgent Medical Device Correction Urgent Field Safety Notice dated November 6, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to ensure that the plan was not converted unintentionally during import/export. Customers would be contacted by a Customer Service Representative when the correction was available to schedule installation on their system. Customers with questions were instructed to contact their local Varian Medical Systems Customer Support District or Regional Manager. US and Canada 1-888-827-4265. For questions regarding this recall call 650-424-5731.

Device

Device Recall Varian brand ARIA Radiation Oncology
  • Modelo / Serial
    CODES:  HITOO28, HIT0963, HITl780, HIT242S, HIT4118RI, HIT0632M, HITIS87R4, HIT2208RS, HID088R6, HITOO32, HIT0983M, HITl800, HIT2434, HIT4263, HlT0632Rl, HlTlS89M, HIT2212, HIT3097, HITOO49M, HIT0983RI, HITI8S4, HIT244I, HIT438I, HIT0632R2, HITlS89Rl, HlT2237M, HIT316S, HITOl16M, HIT0983R2, HITl874, HIT2477M, HIT4439RI, HIT0668, HITIS89R2, HlT2237RI, HIT3206, HITOI16RI, HIT0998, HITl898, HIT2477RI, HIT4SSS, HIT0691M, HITIS89R3, HIT2267M, HIT3267, HIT0134, HITI036, HITl9S8, HlT2477R2, HIT4S92, HIT0691RI, HlTlS89R4, HlT2267RI, HIT3268, HITOISS, HITl119M, HITl968, HIT2477R3, HIT4627, HIT0691R2, HITlS89RS, HIT227SM, HIT3308, HITOI70M, HITII19RI, HIT2037M, HIT2SI2M, HIT477I, HIT0691R3, HITlS89R6, HIT227SRI, HIT3438M, HITOI70RI, HITI139, HIT2037RI, HIT2SI2RI, HlT4800, HIT0764, HITlS89R7, HIT227SR2, HIT3S13, HITOI70R2, HITll49M, HIT2037RII, HIT2S22, HIT4884, HIT0816, HITIS89R8, HlT227SR3, HIT3679, HITOI70R3, HITll49Rl, HIT2037R12, HlT2S46, HIT4888M, HIT0828, HITIS89R9, HIT227SR4, HIT3764RI, HlTOl82, HITI184Al, HIT2037RI3, HIT2S63M, HIT4888RI, HIT08S2, HITI622, HlT2291M, HlT377S, HITOl83, HlTll84M, HIT2037R14, HIT2S63RI, HIT4888R2, HIT090lM, HITI660M, HIT229IRI, HlT3796, HITOl91M, HITll84RI, HIT2037RIS, HIT2S63R2, HIT4888R3, HIT090lRI, HlTl660R2, HIT2291R2, HID910, HITOl91RI, HITI229, HIT2037R16, HIT2S63R3, HIT4894, HIT0926, HITl660R3, HlT2291R3, HIT3927M, HITOI91R2, HITI277, HIT2037R17, HIT2S63R4, HIT4896, HIT0933M, HlTI671, HIT2291R4, HlT3927RI, HIT0227, HITl363M, HlT2037R2, HIT2S91, HIT4903, HIT0933RI, HITl693, HIT229IRS, HlT3927R2, HIT0337M, HITl363RI, HlT2037R3, HIT26IS, HlT4906, HIT0933R2, HITl726, HIT2291R6, HIT394S, HIT0337RI, HITl4I2, HlT2037R4, HIT2643, HIT4909, HIT0933R3, HITl7S7, HlT2293, HlT3967, HIT0337R2, HITl430M, HIT2037RS, HlT264S, HlT4932M, HIT0933R4, HITl764M, HIT2336M, HIT4014, HIT0337R3, HITl430RI, HIT2037R6, HIT2834, HIT4932RI, HIT0933RS, HITI764RI, HIT2336RI, HIT4107, HIT0339M, HITI430R2, HIT2037R7, HIT286S, HIT4938, HIT0933R6, HITl767M, HIT2346M, HIT41l6, HIT0339RI, HITl430R3, HIT2037R8, HIT2894M, HIT4942M, HIT0933R7, HITI767RI, HIT2346RI, HIT41I8M, HIT0341M, HITI470M, HIT2037R9, HIT2894Rl, HIT4942RI, HIT0341RI, HITl470RI, HIT2067, HIT2894R2, HIT4947, HIT0342, HITl470R2, HIT209S, HIT2894R3, HIT4974, HIT0383, HITI498, HIT2102, HlT2943, HIT4975, HIT0397, HITlSI4, HIT2140, HlT29S3, HIT4982, HIT0432M, HITlS23M, HIT2I80, HIT2997, HITSOII, HIT0432RI, HITlS23RI, HIT2188, HIT3088M, HITS048, HIT0432R2, HITIS7S, HIT2208M, HIT3088RI, HITS061, HIT0468M, HITlS87M, HIT2208Rl, HIT3088R2, HITS088, HIT0468RI, HlTlS87RI, HIT2208R2, HIT3088R3, HITS089, HITOS3S, HlTlS87R2, HIT2208R3, HIT3088R4, HITSI16, HITOSSI, HITIS87R3, HIT2208R4, HIT3088R5, HITSl41
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution
  • Descripción del producto
    Varian brand ARIA Radiation Oncology, ARIA Oncology Information System Radiation Oncology, Import Export Application, Model Number: HIT, Affected Versions: ARIA version 11.0 below 11.0.55, Build 11.0.28 and 11.0.34, Reference/FSCA Identifier: CP-09798; || Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA
  • 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