Events

Alerta De Seguridad para Ingenia, Intera, Achieva and Multiva MR systems using R5.1.1 and R5.1.2 version of software

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
    2014-05-08
  • Fecha de publicación del evento
    2014-05-08
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140508a.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: philips healthcare ingenia, intera, achieva and multiva mr systems using r5.1.1 and r5.1.2 version of software medical device manufacturer, philips healthcare, has issued a medical device safety alert concerning its ingenia, intera, achieva and multiva mr systems on r5.1.1 and r5.1.2 with the mobiview software option. according to the manufacturer, the cross reference lines of transversal images are displayed in an incorrect position on a fused image which has been generated through mobiview post processing. the cross reference lines are correctly displayed on the unfused stations. the problem can occur when the field of view of the clinical scan stations is below (more towards the feet) the light visor position. in such situation an error is made in calculating the position information. this causes incorrect positioning of cross-reference lines on fused sagittal images. the hazard is only expected in spine examinations, when using a whole spine survey, while the cervical spine is skipped for the clinical scan. there is a risk of misdiagnosis which could lead to incorrect therapy. the risk occurs when cross-reference lines on fused images are relied upon to determine location of transversal images. in mobiview applications other than spine, reference lines are not commonly used to identify or label anatomy because anatomical landmarks are used instead. the manufacturer advises affected users not to perform planning or review planning of transversal images on fused sagittal images which were generated through mobiview post-processing. instead, the planning of transversal scans should only be reviewed on the unfused stations. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 08 may 2014.

Device

Ingenia, Intera, Achieva and Multiva MR systems using R5.1.1 and R5.1.2 version of software
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Philips Healthcare Ingenia, Intera, Achieva and Multiva MR systems using R5.1.1 and R5.1.2 version of software
  • Manufacturer
    Philips Healthcare

Manufacturer

Philips Healthcare
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DH