Events

Alerta De Seguridad para brilliance 64 and ingenuity ct scanners

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
    2015-08-21
  • Fecha de publicación del evento
    2015-08-21
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150821_b.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 brilliance 64 and ingenuity ct scanners medical device manufacturer, philips healthcare, has issued a medical device safety alert concerning its brilliance 64 and ingenuity computed tomography (ct) scanners. the affected ct systems are brilliance 64, ingenuity ct, ingenuity core and ingenuity core128. only systems with the following versions are affected: 4.0.X.Xxxx- any version of 4.0 4.1.Y.Xxxx -only version up to and including 4.1.4. according to the manufacturer, some scans unexpectedly set the axial (z axis) scan length to a greater length than the user set in the plan. the issue occurs only when the following three conditions are met: the plan employs dual-surview the plan requests either a sagittal or a coronal reconstruction the gantry is tilted there is a potential for undesired radiation to areas not intended to be scanned. the manufacturer is not recommending users to stop using the equipment. to eliminate the possibility of the defect from occurring, users are advised to eliminate any one of the three conditions mentioned above which is needed to trigger the behaviour. the manufacturer is developing a new version of software to eliminate the defect. according to the local supplier, the affected product is distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 21 august 2015.

Device

brilliance 64 and ingenuity ct scanners
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Philips Healthcare Brilliance 64 and Ingenuity CT Scanners
  • Manufacturer
    Philips Healthcare

Manufacturer

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