Events

Alerta De Seguridad para XiO Release 4.51 and higher

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

¿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
    2015-09-08
  • Fecha de publicación del evento
    2015-09-08
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150908a.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: impac medical systems xio release 4.51 and higher the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning xio release 4.51 and higher, manufactured by impac medical systems, inc. when fixed wedges are defined in source file maintenance, the user defines a maximum field size allowed for each wedge. this maximum field size is being ignored by the software when both fixed wedges and mlcs are present in a beam. the result is incorrect calculation and delivery of dose outside the physical extent of the wedge. the dose distribution calculated by xio will not match the dose delivered to the patient in regions beyond the physical dimension of the wedge. according to the field safety notice, varian, siemens and elekta linacs with motorized wedges will prevent delivery. however, elekta linacs with third party fixed wedges will not prevent delivery. xio will calculate wedged dose in the region outside of the physical wedge and the linac will deliver open dose. the patient will receive dose that is different from the planned dose and that dose difference can exceed 5%. there is a remote probability of serious injury resulting from this issue. the problem will be resolved in a patch to xio release 5.10. for details, please refer to the fda website:https://www.Gov.Uk/government/publications/safety-information-from-manufacturers-field-safety-notices/field-safety-notices-31-august-to-4-september-2015 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 8 september 2015.

Device

XiO Release 4.51 and higher
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: IMPAC Medical Systems XiO Release 4.51 and higher
  • Manufacturer
    IMPAC Medical Systems

Manufacturer

IMPAC Medical Systems
  • Empresa matriz del fabricante (2017)
    Elekta AB
  • Source
    DH