Events

Alerta De Seguridad para Mammography Device: Mammography Device: Mammography Device: Mammography Device: Mammography Device: Mammography Device: Mammography Device: Mammography Device: Mammography Device: ANVISA Registration Number: 10345162027 Class Affected: MAMMOMAT Inspiration Serial numbers affected: 3063, 3400, 3630, 3639, 3746, 3828, 4169, 4275, 4276, 4451, 4704, 4708, 4710, 5047, 5078, 6044, 6204, 6488

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Siemens Healthcare Diagnósticos S.A; Siemens AG.

¿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
    2282
  • Fecha
    2017-04-27
  • 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
    To avoid the problem of inactivating the biopsy functionality, when the error message is displayed, the user is advised not to close the window but cancel the active target first and then close the error message window. After completing these steps, the user can start from the beginning. It is advisable not to use the inversion tool while the scout image is active. In the event of system crash, the Acquisition Workplace must be restarted. The software update will be offered to customers to solve the problem.
  • Causa
    The company has identified in mammomat inspiration systems with vb30 software version and with biopsy functionality that there is a potential for potential error that blocks the biopsy functionality, leaving it unavailable in situations where there is a compression force decrease or when there is use of the tool. inversion while the scout image is active during the targeting phase.
  • Acción
    Field Action Code XP041 / 16 / S triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will make correction in the field.

Device

Mammography Device: Mammography Device: Mammography Device: Mammography Device: Mammography Devic...

Manufacturer

Siemens Healthcare Diagnósticos S.A; Siemens AG
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA