Events

Alerta De Seguridad para COMPASS 3.1 / 3.1a

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

¿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
    2015-02-16
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150216.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
    Medical device safety alert: iba dosimetry compass 3.1 / 3.1a medical device manufacturer, iba dosimetry, has issued a field safety notice concerning compass 3.1 / 3.1a [catalogue number: cs10-100. manufacturing date: may 2014 (for version 3.1) and nov 2014 (for version 3.1a)]. the manufacturer found that dose reconstruction for dmlc plans from monaco or eclipse-11 when the jaws move or mlc leaves reverse during beam on was not scaled correctly. normally, during the measurement-based correction process employed by compass, a step called “delivery error scaling” is carried out in order to correct for an overall absolute dose difference level between measured and predicted responses. a scale factor derived from this difference in absolute output is averaged over all detector pixels. the error occurs as the “delivery error scaling” is not properly applied. the reconstructed dose becomes erroneous although the predicted response remains correct. the error occurs when compass is used to acquire measurement data and the evaluation is performed using reconstructed dose. if the predicted response is not evaluated together, the erroneously reconstructed dose may not be noticed. this could happen if the measurement shape is correct but the absolute level is wrong. the manufacturer will provide software update to correct this issue. according to the local supplier, the affected product is distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. 16 february 2015.

Device

COMPASS 3.1 / 3.1a
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: IBA Dosimetry COMPASS 3.1 / 3.1a
  • Manufacturer
    IBA Dosimetry

Manufacturer

IBA Dosimetry