Events

Alerta De Seguridad para Mammo Graph Mammo and Mammo DR Mammography Unit, records 10216710296 and 10216710243, risk class III, serial number of affected equipment and municipalities located: PADPVG01001 - SANTA ROSA; PADPXU01001 - FRUTAL ;. PADPVG02001 - CERES ;. PADPW801001 - LAGES ;. PADPVG03001 - TERESINA ;. PADQKC01001 - GOIANIA ;. PADQKC02001 - IMPERATRIZ ;. PADRNO02001 - JARU ;. PADRWY02001 - ARAPIRACA ;. PADRNO01001 - AMARANTE ;. PADRWY01001 - CAPANEMA ;. PACZUO01001 - CACOAL ;. PAD63801001 - GOIANIA; PADED101001 - RIO VERDE ;. PADKZ801001 - MONTENEGRO.

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..

¿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
    1714
  • Fecha
    2015-05-07
  • 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 record holder's information, if the gears are disengaged, the patient under examination procedure and with the compressed breast would be exposed to the risk of a potential adverse event due to the involuntary twisting of the 180 ° arm. The event has a high chance of occurrence. #### UPDATED ON 07/18/2017, the company sent a report of completion of the field action proving the accomplishment of correction, as planned.
  • Causa
    Possibility that the internal gears used for the rotating movement of the mammograph arm disaggregate due to inverted mounting of a mechanical component called "bearing spacer".
  • Acción
    The company will correct the position of the "bearing spacer", which will allow adjustment of the entire assembly, located on the arm of the mammograph. Customers must schedule a technical visit to perform this action. Any questions get in touch with the company. Action code: FCOLAS 002-2015.

Device

Mammo Graph Mammo and Mammo DR Mammography Unit, records 10216710296 and 10216710243, risk class ...

Manufacturer

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