Alerta De Seguridad para Commercial name of the product: PCR Eleva /// Registration number: 10216719006 /// Models affected: S / S Plus / S Hi-res / Cosimax / Corado / Compact /// Serial number affected: 36626334./// Class risk of the product: I.

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 / Philips Medical Systems (Lagoa Santa)..

¿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
    1983
  • Fecha
    2016-09-16
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • 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
    Philips plans to replace the system's power supply unit of the Compano Basic PCR scanner, which will eliminate this problem. A Philips Maintenance Engineer will contact you as soon as the Action Kit is available to be implemented. /// If you need to communicate with Philips about this program, please refer to Amendment Request 73200037./// If you need more information or support for this issue, please contact our Philips Solution Center through telephone 0800-701-7789. Service from Monday to Saturday from 07h to 19h.
  • Causa
    A faulty component of the compano reader's power supply may cause the power supply to burn and produce smoke in the compartment.
  • Acción
    Field classification: Field correction by replacing the power supply unit of the PCR reader system Basic affected /// Field action code: FCO73200037 /// Recommendations to users and patients: The system can be used in accordance with the Instructions for Use without restrictions. In case of fire, the user may alert the fire department, use an extinguisher and / or evacuate the premises.