Events

Alerta De Seguridad para COMPASS Software version 3.1

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

¿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
    2014-10-23
  • Fecha de publicación del evento
    2014-10-23
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141023b.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 gmbh compass software version 3.1 medical device manufacturer, iba dosimetry gmbh, has issued a medical device safety alert concerning its compass software version 3.1 [catalogue number: cs10-100]. based on a customer complaint the manufacturer identified that compass 3.1 has an error in the reconstruction of the dose distribution for specific plans: monaco-dmlc and eclipse imrt plans with jaw tracking- option enabled. the reconstruction results in the same dose distribution as the dose computation, which has the potential of being erroneous. based on this information the manufacturer performed a health hazard analysis for compass 3.1and determined that this failure may have an impact on the intended use of compass. the evaluation of the risk for the patient resulted in a region where a risk reduction is necessary. therefore, the affected customers have to be informed about the malfunction in the software. additionally the medical device compass 3.1 has to be corrected. affected users are advised not to apply patient plan verification for monaco-dmlc and eclipse imrt plans with jaw tracking option enabled using the 3d dose reconstruction (measurement-based) calculation method with compass 3.1 until the corrected version is available and installed. according to the manufacturer, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 23 october 2014.

Device

COMPASS Software version 3.1
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: [23 Oct 2014] IBA Dosimetry GmbH COMPASS Software version 3.1
  • Manufacturer
    IBA Dosimetry GmbH

Manufacturer

IBA Dosimetry GmbH