Alerta De Seguridad para ingenia, intera, achieva and achieva dstream mr systems

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

¿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
    2014-08-12
  • Fecha de publicación del evento
    2014-08-12
  • País del evento
  • Fuente del evento
    DH
  • URL de la fuente del evento
  • 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: philips healthcare ingenia, intera, achieva and achieva dstream mr systems medical device manufacturer, philips healthcare, has issued a field safety notice (fsn) concerning its ingenia, intera, achieva and achieva dstream mr systems on r5.1 .7 and r5.1 .8 with the mobi view software option. according to the fsn, when scrolling through mobiview fused sagittal/coronal images, the actual display order of the images on the screen is opposite to previous releases. this behaviour is seen on the mr console as well as on workstations and the picture archiving and communication system (pacs). the slice numbering of fused sagittal and coronal images is reversed compared to the unfused sagittal and coronal images. as a result, source image slice 1 becomes fused image slice 9 in sagittal/coronal direction, and vice versa. the slice numbering is correct in the transverse direction. the manufacturer advises users of the followings: to avoid possible confusion, the unfused images, transverse images and anatomical landmarks should be included in reading the examination. both unfused and fused images should be exported to the pacs and workstations. furthermore, the manufacturer plans to create a field change order to install updated software in a service pack that makes the slice numbering consistent for fused and unfused images. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 12 aug 2014.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Philips Healthcare Ingenia, Intera, Achieva and Achieva dStream MR systems
  • Manufacturer

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    DH