Events

Alerta De Seguridad para Mammography Unit Graph-Mammo AF, registry: 10216710241, risk class III, Philips Brand; models: PABI8101001 / PACHD401001

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.

¿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
    1557
  • Fecha
    2015-03-05
  • 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
    According to the registry holder, there is a low probability of this failure resulting in the breaking of the equipment bearing, which causes the arm to tilt about fifteen degrees toward the patient. If the event occurs during the examination, there is a risk of injury to the patient.
  • Causa
    Product received with broken bearing weld.
  • Acción
    For safety reasons, according to the manufacturer, if the problem is detected in the equipment, an immediate suspension of use will be requested and the customer must request a repair appointment for the equipment by a qualified technician.

Device

Mammography Unit Graph-Mammo AF, registry: 10216710241, risk class III, Philips Brand; models: PA...

Manufacturer

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