Events

Alerta De Seguridad para Commercial Names: CT Scanning System / Ingenuity CT; ANVISA registration numbers: 10216710191/10216710209; Risk class: III; Affected models: Brilliance 64, Ingenuity Core, Ingenuity Core128; Affected serial numbers: 10782, 10768, 10777, 10770, 10769, 95839, 95841, 95840, 95866, 95847, 95863, 95846, 95846, 320113.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Philips Medical Systems Ltda.; Philips Medical Systems (Cleveland), Inc. / Philips Medical Systems Ltda.

¿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
  • ID del evento
    1892
  • Fecha
    2016-05-06
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notas adicionales en la data
    Philips Healthcare is implementing the software version 3.5.5 upgrade to correct the problem described above. Solution Center will contact you to schedule the software update installation on your site. If you need more information or support for this issue, please contact our Solution Center at 0800-701-7789. Service from Monday to Saturday from 07 to 19h.
  • Causa
    Philips healthcare received field reports stating that certain brilliance 64, ingenuity core and ingenuity core128 systems running software version 3.5.4 exhibited intermittent swirl-like circular artifacts that may appear on rebuilt images and may diagnosis of affected images. the clinician should apply clinical judgment to determine if the images contained in the data set without artifacts contain enough information to make a diagnosis. if these images are sufficient, no action is required. if the images are not sufficient, a new patient scan may be required.
  • Acción
    Action code FCO72800597. Software update

Device

Commercial Names: CT Scanning System / Ingenuity CT; ANVISA registration numbers: 10216710191/102...

Manufacturer

Philips Medical Systems Ltda.; Philips Medical Systems (Cleveland), Inc. / Philips Medical System...
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    ANVSANVISA