Events

Alerta De Seguridad para brilliance ct 64, ingenuity core and ingenuity core128 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
    2013-05-03
  • Fecha de publicación del evento
    2013-05-03
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130503.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 brilliance ct 64, ingenuity core and ingenuity core128 systems medical device manufacturer, philips healthcare issued a medical device safety alert concerning all brilliance ct 64, ingenuity core and ingenuity core128 systems using software versions 2.6.1 or 3.5.4. philips healthcare received reports from the field that certain brilliance ct 64, ingenuity core and ingenuity core128 systems running software versions 2.6.1 or 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images, which may impair the diagnostic quality of affected images. philips healthcare states that there are no proactive actions for the user. clinical judgment should be used by the customer or user to determine if the images contained in the dataset without artifacts contain enough information to make a diagnosis. if these images are sufficient, no further action is required. if the images are not sufficient, a rescan of the patient is required. philips healthcare is implementing software update versions 2.6.2 or 3.5.5 to correct the above-described issue. according to the local supplier, philips electronics hong kong ltd, 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 3 may 2013.

Device

brilliance ct 64, ingenuity core and ingenuity core128 systems
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Philips Brilliance CT 64, Ingenuity Core and Ingenuity Core128 systems
  • Manufacturer
    Philips Healthcare

Manufacturer

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