Events

Alerta De Seguridad para Allura Xper Angiography Equipment Angiography Equipment Angiography Equipment ANVISA Registration Number: 10216710153 Hazard Class: III Model Affected: Allura Xper FD10 Ceiling / Allura Xper FD10 Ceiling / Allura Xper FD20 Ceiling / Allura Xper FD20 Floor / Allura Xper FD10 OR Table / Allura Xper FD20 OR Table Serial numbers affected: 1330; 1308.

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 Nederland B.V..

¿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
    2279
  • Fecha
    2017-04-25
  • 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
    Failure to emit the audible alarm occurs very intermittently. The user should always observe the real-time dose information and cumulative fluoroscopy time provided by the system. The fault condition is reset when the case of a new patient is started or when the system is reset. #### Update of the field action: UPDATED ON 12/11/2017, the company presented the completion report of the field action, with sending of necessary evidences and corrective actions.
  • Causa
    Philips healthcare has identified, through customer complaints and internal testing, an intermittent electronic defect in the product. under certain circumstances, a software error may lead to a situation where the five-minute fluoroscopy beep is not emitted as required in 21cfr1020.32 (h) (2) (ii) and iec 60601-2-54 , clause 203.6.2.1.C. no injuries attributed to the problem were reported.
  • Acción
    Field Action Code FCO72200350 triggered under the responsibility of the company Philips Medical Systems Ltda. Company will make correction in the field.

Device

Allura Xper Angiography Equipment Angiography Equipment Angiography Equipment ANVISA Registration...

Manufacturer

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