Events

Retiro De Equipo (Recall) de ARIA PRACTICE MANAGEMENT - 4D INTEGRATED TREATMENT CONSOLE (4DITC)

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada 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
    108134
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-05-07
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    An anomaly has been identified with 4d integrated treatment console (4ditc) when a physical wedge accessory is prescribed. the 4ditc may erratically fail to load the planned wedge without warning or notification when receiving an approved plan from the oncology information system (ois). after a plan with wedge field has been opened in 4ditc users may not notice that the wedge filter is missing from a selected field. the treatment application will not notify the user of this anomaly and will not prevent beam delivery. the user may become aware that the wedge filter is missing only after the treatment field has been partially or completely delivered and when the user attempts to close the patient from the treatment application. in this situation the treatment application forces the user to unload the patient requires user authorization and informs the user that the treatment record for the missing wedge field will not be saved to the ois. delivery of a treatment field without the planned and calculated wedge filter could result in an over dosage for that beam and potentially an unintended dose uniformity of the target treatment volume.

Device

ARIA PRACTICE MANAGEMENT - 4D INTEGRATED TREATMENT CONSOLE (4DITC)
  • Modelo / Serial
    Model Catalog: V8.1.2 (Lot serial: >10 SERIAL NUMBERS.); Model Catalog: V8.6 (Lot serial: >10 SERIAL NUMBERS.); Model Catalog: V8.8 (Lot serial: >10 SERIAL NUMBERS.); Model Catalog: V8.1.2 (Lot serial: CONTACT MANUFACTURER.); Model Catalog: V8.6 (Lot serial: CONTACT MANUFACTURER.); Model Catalog: V8.8 (Lot serial: CONTACT MANUFACTURER.)
  • Descripción del producto
    Aria Practice Management
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.