Events

Alerta De Seguridad para Commercial Name: Brightview XCT Image System Technical Name: Equipment Positron Emission Tomography ANVISA Registration Number: 10216710189 Hazard Class: III Model Affected: Serial Numbers Affected: 6000276

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
    2215
  • Fecha
    2017-03-02
  • 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
    Discontinue use of the system immediately, until the Philips service implements the inspection, and if necessary, the correction. #### UPDATED ON 7/18/2017, the company submitted a completion report of the field action informing the proof of compliance of product.
  • Causa
    The detector locking systems may become inoperative, resulting in movement to the mechanical limit of one or both of the detectors. in the case of this type of fault, the movement of the detector can not be suspended using normal operator intervention (e-stop, activation of the collimator contact sensor).
  • Acción
    Field Action Code FCO88200502 triggered under the responsibility of the company Philips Medical Systems Ltda. Company will make correction in the field.

Device

Commercial Name: Brightview XCT Image System Technical Name: Equipment Positron Emission Tomograp...

Manufacturer

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