Events

Alerta De Seguridad para X-ray System for Computed Tomography, Model MX 16-Slice, Registration nº 10216710193. Serial numbers: Attachment

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 and Neusoft Medical Systems Co. LTD.

¿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
    1483
  • Fecha
    2014-11-28
  • 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
    The company informs that there is possibility of incorrect diagnosis or classification of incorrect anatomy, leading to treatment / procedure not necessary, although the probability of occurrence has been classified as not expected
  • Causa
    Philips informs that you have identified that the orientation of the images is displayed incorrectly. when the operator chooses "gantry on the right side" on the operation control panel, and the patient position is hfdl, hfdr, ffdl, or ffdr, the patient position figure and text are not compatible. "l" and "r" ("left" and "right") of the examination images are inverted and this is not compatible with the current position of the patient.
  • Acción
    Philips Healthcare instructs that: 1. When the error is found, restart the Console and Application software. 2. Avoid using the "Gantry on the Right side" guideline to examine patients. 3. After the Console starts, wait a few minutes, and then start the application software. Further information in the annex: Safety Notice.

Device

X-ray System for Computed Tomography, Model MX 16-Slice, Registration nº 10216710193. Serial numb...

Manufacturer

Philips Medical Systems Ltda.; Philips and Neusoft Medical Systems Co. LTD
  • Source
    ANVSANVISA