Alerta De Seguridad para RM Magnetom apparatus, Open model, Impact and Vision, registration 10234230012, series: 7449; 5709; 9190; 15024; 15517 /// RM Magnetom Symphony Equipment, registration 10234230057, series: 13131; 13286; 13424; 13564; 22202; 22379; 22388; 22389; 22448; 22460; 22583; 22744; 23207; 23286; 37503. /// Equipment of RM Magnetom Sonata, registration 10234230089, series: 21120; 21179; 21271 /// Equipment of RM Magnetom Spectra, registration 10345161996 (original registration 10234230182), series: 73002; 73003 /// Magnetom Avanto, registration 10345162003 (original registration: 10234230095), series: 57140; 57206; 57241; 59081. /// Magnetom Essenza, registration 10345162004 (original registration 10234230155), series: 64132; 71310; 71326; 71330; 71338; 71341; 71343; 71347; 71349; 71350; 71355; 71357; 71358; 71359; 71361; 71362; 71365; 71366; 71381; 71384. /// Equipment of RM Magnetom Prisma, registration 10345162015 (original registration 10234230203), series: 67047; 67051. /// Equipment of RM Magnetom Aera, registration 10345162032 (original registration 10234230175), series: 41904; 41909; 41986; 42031; 53501; 53502. /// Magnetom Harmony Equipment, registration 10234230056.

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; Siemens Shenzhen Magnetic Resonance Ltd.; Siemens Healthcare Diagnósticos S.A.

¿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
  • Fecha
  • País del evento
  • Fuente del evento
  • 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
    Suppressor lines in magnetic resonance systems serve to vent helium gas in case of dissipation. In the event of installation failure, the helium gas would be blown into the magnet room or other areas. This could lead to a displacement of the local oxygen gas, cause cold burns and / or pose a risk to users, patients and others.
  • Causa
    Siemens healthcare comes across the letter mr047 / 15 / s to alert its customers in brazil about the possibility that the suppressor lines of some superconducting magnets have not been installed properly.
  • Acción
    The field action code MR047 / 15 / S initiated by Siemens addresses the sending of a Risk Letter III to the Customer (situation in which there is a low probability that the use or exposure to a health product may have adverse health consequences ). Recommendation to Users and Patients: Proprietary MRI customers must follow one of the steps below, depending on who performed the MRI suppression facility. The guideline is for customers to have the equipment inspected for installation to assess the existence of the problem. 1) If Siemens has been contracted to install the suppressor line, contact the local Siemens organization for appropriate action. 2) If a third party has been contracted to install the suppressor line, it is recommended that they be contacted and requested to inspect the suppressor line in order to ensure that it has been installed in accordance with the system owner's manual and in accordance with requirements in the design document of the Siemens suppressor line. Notwithstanding, and alternately, Siemens makes itself available to offer users the possibility of requesting an inspection of the installation, after which it will be informed of the result and any identified deficiencies that need to be resolved. Finally, it is important to note that it is important to follow all the guidelines mentioned in the system owner's manual, including ensuring that there is an on-site emergency plan in the event of helium gas dissipation to the magnet room or adjoining rooms.