Events

Retiro De Equipo (Recall) de Varian RPM System version 1.7.3

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.

¿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
    45519
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0554-2008
  • Fecha de publicación del evento
    2008-01-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-09-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65722
  • 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 Medical Accelerator - Product Code IYE
  • Causa
    Erroneously resetting: rpm system version 1.7.3, software failure can occur that affects the gated radiotherapy treatment when phase-based gating is used. rpm 1.7 erroneously resets the phase-based gating thresholds to system default during the treatment session, if the user accesses the session options during the treatment session. this can lead to difference between the planned and delivered.
  • Acción
    Varian sent an Urgent Medical Device Correction letter on September 26, 2007, to all its direct consignees, informing them that the RPM version 1.7 may reset the phase thresholds if Sessions options are accessed during treatment. A Service Representative will be scheduling a visit to user site to perform the modification requested to address the problem, when a corrected software version is available.

Device

Varian RPM System version 1.7.3
  • Modelo / Serial
    Serial Number:  H502244, H502211, H502203, H502183, H502179, H502178, H502169, H502167, H502166, H502154, H502152, H502138, H502137, H502136, H502133, H502132, H502131, H502130, H502126, H502121, H502119, H502118, H502117, H502116, H502112, H502110, H502107, H502104, H502103, H502102, H502096, H502060, H502057, H502045, H502002, H501999, H501983, H501930, H501907, H501904, H501869, H501838, H501577, H501412, H501367, H501329, H501325, H501306, H501290, H501259, H501246, H501222, H501214, H502051, H502067, H500395, H500406, H500853, and H502066
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide including countries of: Ireland, Italy, Spain, UK, Denmark, Finland, France, and Canada
  • Descripción del producto
    Varian Real-Time Position Management System (RPM), A Respiratory Gating System; Version 1.7.3, All Models; Varian Medical Systems, Palo Alto, CA 94304
  • Manufacturer
    Varian Medical Systems Inc

Manufacturer

Varian Medical Systems Inc
  • Dirección del fabricante
    Varian Medical Systems Inc, 911 Hansen Way, Palo Alto CA 94304
  • Source
    USFDA