Events

Alerta De Seguridad para X-RAY SYSTEM FOR COMPUTERIZED TOMOGRAPHY. Anvisa Registry No. 10216710193. Affected units: EP16E100069, EP16E110084, EP16E110014, EP16E110044, EP16E110083, EP16E110012, EP16E110021, EP16E110008, EP16E110070, EP16EB110003, EP16EB110004, EP16EB110005 and EP16EB110006.

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..

¿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
    1190
  • Fecha
    2012-10-05
  • 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
    According to the company, if the oil accumulator or other parts are released and the Gantry covers are open while the appliance is in maintenance mode, the maintenance engineer may be struck by the accumulator of ejected oil or other parts. The company's forecast is to terminate the action on 03/22/2012.
  • Causa
    A bolt that secures the oil accumulator inside the gantry may fail, resulting in the separation of the oil accumulator from the tube mounting inside the gantry.
  • Acción
    Check your inventory if you have the affected products, if so, carefully read the instructions in the Alert of the product registration holder (Philips Medical Systems Ltda) and, if necessary, contact the company. The equipment serial number is located on the back of the Gantry. Detailed information to identify your system is available in Appendix B of the Alert Message posted by the company - www.xxxxx.

Device

X-RAY SYSTEM FOR COMPUTERIZED TOMOGRAPHY. Anvisa Registry No. 10216710193. Affected units: EP16E1...

Manufacturer

Philips Medical Systems Ltda.
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    ANVSANVISA