Events

Retiro De Equipo (Recall) de ON-BOARD IMAGER

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
    131793
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-06-30
  • 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 in the 3d match environment of obi 1.3 obi 1.4 obi 1.5 truebeam 1.0 and offline review 1.0 - 2.0 when using reference ct datasets which contain a critical number of slices. [note that the 3d match environments of truebeam 1.5 and offline review 2.1 are not affected by this anomaly.] when these reference ct datasets are used to create a reference ct volume in the 3d match environment in a small number of cases the scaling of the ct volume will be incorrect and the ct volume will appear larger - in the slice direction - than it actually should be. if this improperly scaled ct volume is used for 3d matching the cbct volume and patient may be positioned too far superiorly. because of differences in software design obi 1.5 is much more likely to exhibit this behavior than the other products identified.

Device

ON-BOARD IMAGER
  • Modelo / Serial
    Model Catalog: OBI (Lot serial: Contact manufacturer.); Model Catalog: TRUEBEAM (Lot serial: H191038); Model Catalog: OBI (Lot serial: >10 serial numbers.); Model Catalog: TRUEBEAM (Lot serial: H191071); Model Catalog: TRUEBEAM (Lot serial: H191044); Model Catalog: TRUEBEAM (Lot serial: H191069)
  • Descripción del producto
    On Board Imager
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.