Events

Alerta De Seguridad para X-ray apparatus, Compact Plus, Risk class III, registration 10216710251, series / lots affected in annex.

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 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
    1632
  • Fecha
    2015-07-03
  • 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 information of the holder, in the event of cable breakage and failure of the rubber safety lock, the assembly may slide along the column without speed control, depending on the degree of elevation. In this case the patient under procedure would be exposed to the risk of an adverse event. #### UPDATED ON 07/18/2017, the company sent a report of completion of the field action proving the accomplishment of exchange, as planned.
  • Causa
    According to the record holder, there is a possibility that the steel cable component, used to lift the suspension mass of the arm assembly, x-ray tube and collimator, can break after a period of heavy equipment use due to the continuous contact with some mechanical parts inside the stationary (spring or motorized) column.
  • Acción
    The company issued two safety notices. For customers who received the 001 (FSN) notice, the recommendation is to discontinue use of the equipment and wait for a preliminary inspection of the cable for action by the field engineer. For customers who received the 002 (FSN) communiqué, the equipment will not need to be interrupted and customers should wait for the scheduling of the service by the field engineer to exchange the parts involved

Device

X-ray apparatus, Compact Plus, Risk class III, registration 10216710251, series / lots affected i...

Manufacturer

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