Events

Alerta De Seguridad para DigitalDiagnost Radiology System - Registration No. 10216710214, Serial Numbers: 13000321, 426121 / SN09000086, 426122 / SN09000092, 456396 / SN10000277, 483715 / SN11000504, 512026 / SN12000272, 514483 / SN13000004, 521862 / SN13000033

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 DMC GmbH.

¿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
    1502
  • Fecha
    2014-11-05
  • 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
    The company makes it clear that if the hook does not securely support the feet in an upright position, the support may fall and injure the operator or patient. #### UPDATED 7/18/2017, the company submitted field action proving the replacement of the part as planned.
  • Causa
    The platform for the entire column exams can be fixed in the upper position. when the clamp (hook) is not adjusted in its correct position, the foot support is not secured securely. if it falls, it may hurt the operator's or patient's foot (for example, when moving the stand or when the operator can not fix it correctly when moving the stand up). the following factors are necessary for this situation to occur: - hook not properly adjusted - operator does not recognize that the hook is not engaged in the correct place - patient support is moved (rotated) - hook is not secure - foot is in "risk area".
  • Acción
    The customer / user should always check the correct hook position and whether the hook is locked. (Press the hook down until it locks in place) Ensure that the hook is in the position shown in the figure with the green arrow (at the safety warning).

Device

DigitalDiagnost Radiology System - Registration No. 10216710214, Serial Numbers: 13000321, 426121...

Manufacturer

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