Events

Alerta De Seguridad para Digital Mammography Unit, MAMMOMAT Inspiration - Model: MAMMOMAT Inspiration - Record: 10234230164 - Risk Class III - High Risk - Technical Name: Mammography Unit - Series: 3064; 5047

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 Ltda.; 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
    1462
  • Fecha
    2014-10-20
  • 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
    The company recommends "(...) inspect the safety switch before each biopsy until the problem is solved and then carefully follow the instructions in the user manual - safety switch chapter. The customer will be advised to wait for the Service Team to schedule field corrections and to file the letter with the Operator's Manual. In addition, Siemens advises to inform all personnel of the organization who need to be aware of this problem and act accordingly. Send this safety information to any other institutions that may be affected by this measure. "
  • Causa
    Problem: according to the company: "stereotactic biopsy devices for mammomat inspiration mammography systems may have integrated a safety switch that causes a functionality failure. the pin included in the safety switch may not exert sufficient pressure on the safety circuit to prevent movement. the needle positioner can move even with the safety switch on the side. if this occurs with the needle already inserted, it can lead to an unintentional injury to the patient. ".
  • Acción
    Company will perform Correction in the field. Code: XP053 / 14 / S

Device

Digital Mammography Unit, MAMMOMAT Inspiration - Model: MAMMOMAT Inspiration - Record: 1023423016...

Manufacturer

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