Events

Alerta De Seguridad para OBI 1.3, OBI 1.4; OBI 1.5; TrueBeam 1.0; Offline Review 1.0 - 2.0

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Varian.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2011-11-17
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111117b.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Field safety notice: varian obi 1.3, obi 1.4; obi 1.5; truebeam 1.0; offline review 1.0 - 2.0 medical device manufacturer, varian, has issued an urgent medical device correction concerning obi 1.3, obi 1.4; obi 1.5; truebeam 1.0; offline review 1.0 - 2.0. 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. 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. according to the local supplier, the affected device has been distributed in hong kong. varian has notified all possibly affected customers and developing a correction for this issue. if you are in possession of the affected products, please contact supplier for necessary actions.

Device

OBI 1.3, OBI 1.4; OBI 1.5; TrueBeam 1.0; Offline Review 1.0 - 2.0
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Varian OBI 1.3, OBI 1.4; OBI 1.5; TrueBeam 1.0; Offline Review 1.0 - 2.0
  • Manufacturer
    Varian

Manufacturer

Varian