Events

Retiro De Equipo (Recall) de Device Recall Varian Treatment

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
    59572
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3105-2011
  • Fecha de inicio del evento
    2011-07-20
  • Fecha de publicación del evento
    2011-08-31
  • 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=103135
  • 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
    Linear Accelerator for Radiation Therapy System - Product Code IYE
  • Causa
    Potential for varian treatment application failing to load the physical wedge filter for a treatment field on a siemens mevatron linear accelerator. delivery of a treatment field without the planned wedge would deliver more dose than intended and would change the shape of the dose distribution for that field.
  • Acción
    Varian Medical Systems sent out "Urgent Medical Device Correction/Urgent Field Safety Notice" letters dated July 20, 2011 to all affected customers. The letter identified product, problem and provided recommended user actions when setting up and running the system. It also asked customers to notify appropriate personal provided instructions. For information or questions on this recall please call Varian at (888) VARIAN5 (888- 827-4265).

Device

Device Recall Varian Treatment
  • Modelo / Serial
    Model H48; Serial numbers: H460150 H462049 H462100 H463014 H463044 H463077 H466021 H466036 H466051 H466067 H460907 H462050 H462123 H463015 H463052 H463078 H466022 H466037 H466052 H466068 H461000 H462051 H462124 H463016 H463053 H463080 H466023 H466038 H466053 H466069 H462003 H462055 H462127 H463017 H463054 H463082 H466024 H466039 H466054 H466075 H462004 H462057 H463000 H463018 H463061 H463083 H466025 H466040 H466055 H466082 H462005 H462061 H463001 H463020 H463062 H463093 H466026 H466041 H466056 H466086 H462006 H462072 H463004 H463024 H463064 H463218 H466027 H466043 H466059 H466091 H462011 H462079 H463006 H463038 H463065 H463377 H466028 H466044 H466061 H466092 H462024 H462080 H463008 H463039 H463068 H465519 H466029 H466045 H466062 H468097 H462030 H462082 H463010 H463040 H463070 H466001 H466030 H466046 H466064 H468098 H462045 H462089 H463012 H463042 H463071 H466011 H466031 H466047 H466065   H462048 H462095 H463013 H463043 H463075   H466017 H466032 H466050 H466066.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: Nationwide distribution including the states of AZ, CA, FL, GA, IN, MA, MD, MI, MN, MO, NJ, NY, PA, SC, TN, VA and WV; and the countries of Canada, Austria, Belgium, Brazil, Denmark, Finland, France, Germany, India, Ireland, Italy, Lithuania, Poland, Portugal, Romania, South Africa, South Korea, Spain, Sweden, Switzerland and UK.
  • Descripción del producto
    Varian Treatment version 6.6.5052. || Varian Medical Systems, || Palo Alto, Ca || Intended to provide accurate treatment set-ups for each patient by monitoring linear accelerator set-up parameters and by preventing the radiation therapy device form commencing irradiation while any linear accelerator parameter is out of conformance with the treatment plan.
  • 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