Events

Alerta De Seguridad para MAGNETIC RESONANCE IMAGE SYSTEM, Models and records: SEE CUSTOMER LETTER. ///. This fix applies to units of the following GE Healthcare IRM systems: Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, GE 1.5T Signa HDe, Optima MR360, Brivo MR355, Signa Excite-HD 1.5T & 3T , Signa Excite 3.0T, Signa Contour / I, Signa OpenSpeed, Vectra, MR Max, Optima MR450w GEM, Discovery MR750W GEM, Optima MR450w, Signa Profile and Signa Ovation.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por GE Healthcare do Brasil; GE Medical Systems, LLC.

¿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
    1540
  • Fecha
    2015-03-13
  • 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
    Failure to update the software may result in errors in image orientation. Errors of this nature may result in inaccuracy in treatment.
  • Causa
    As described by the company "as of 12/11/2014 ge healthcare became aware that the latest version of the equipment's current software may not have been reinstalled in some facilities after performing maintenance services that require the software to be recharged . the latest implemented version of the software may include security updates. ".
  • Acción
    According to company information, all affected systems will be inspected and ensured that the appropriate version of the software is installed, free of charge. The systems that allow this action will be checked remotely (online), and will visit the establishments where remote verification is unavailable.

Device

MAGNETIC RESONANCE IMAGE SYSTEM, Models and records: SEE CUSTOMER LETTER. ///. This fix applies t...

Manufacturer

GE Healthcare do Brasil; GE Medical Systems, LLC