Events

Alerta De Seguridad para Magnetic Resonance Imaging Equipment, SIEMENS Brand, Risk Class II, of the following models :. - Magnetom Aera / Magnetom Skya, Registry: 10234230175 ///. - Magnetom Avanto, Registry: 10234230095 ///. - Magnetom Espree, Registry: 10234230115 ///. - Magnetom Essenza and Verio, Registry: 10234230155 ///. - Magnetom Harmony, Registry: 10234230056 (hazard class III) ///. - Magnetom Sonata, Record: 10234230089 ///. - Magnetom Spectra, Registry: 10234230182 ///. - Magnetom Symphony, Registry: 10234230057 ///. - Magnetom Trio, Registry: 10234230098 ///. Serial numbers: attached.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Siemens Ltda.; SIEMENS AG Medical Solutions Group..

¿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
    1515
  • Fecha
    2014-11-24
  • 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 holder of the registration informs: "The possibility of a rupture in the quench tube, which may cause the helium gas to leak into the magnetic room or any other area near the quench tube. In rare cases, this helium gas may lead to a displacement of oxygen in the air causing danger by asphyxiation in people in the area. Other hazards, such as freezing, can be caused by the extremely low temperatures of helium gas. #### UPDATED ON 08/21/2017, the field action documentations submitted by the company are filed in the area. If necessary, the area can reassess the action at any time.
  • Causa
    Siemens has detected that in some cases siemens magnetom systems with superconducting magnets may have been installed by omitting essential safety requirements for the installation of the quench tube.
  • Acción
    The registration company advises users to wait for the quench tube check by the Siemens team. If, during the inspection, you detect any discrepancies with the requirements of Siemens, the user will be informed separately about the type of divergence together with a plan of how it will be corrected. (SEE ANNEX CUSTOMER LETTER)

Device

Magnetic Resonance Imaging Equipment, SIEMENS Brand, Risk Class II, of the following models :. - ...

Manufacturer

Siemens Ltda.; SIEMENS AG Medical Solutions Group.
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA