Events

Retiro De Equipo (Recall) de Varian RPM Respiratory Gating System

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand 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
    14570
  • Fecha de inicio del evento
    2013-04-29
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Varian Medical Systems Australasia Pty Ltd (NZ), C/- BDO Auckland - Christine Koefoed, Level 4, BDO Centre, 4 Graham Street, Auckland 1140
  • Causa
    Manufacturer has identified an anomaly with the rpm respiratory gating system. while operating with the 6-dot marker block, this version of the rpm gating may produce an inverted respiratory waveform in amplitude and phase-gating sessions., the error may be reproduced if the rpm system is induced to frequently lose and re-acquire tracking of the 6-door marker block during a calibration sequence, a reference session or a single session after tracking has begun.
  • Acción
    Software to be upgraded

Device

Varian RPM Respiratory Gating System
  • Modelo / Serial
    Model: H50, Affected: 1.7.5 with 3D option SN's: H501056, H501080, H501944, H502289, H502300, H502301, H503567, H503596, H503935, H504201 and H504724.
  • Manufacturer
    Varian Medical Systems Inc

Manufacturer

Varian Medical Systems Inc