Events

Alerta De Seguridad para X-Ray System PROTEUS X / Ra, Hazard Class III, Model 600-0301, Registration: 80071260005, manufactured before January 2011 .. Serial numbers: 00000024890HL6; 00000024891HL4; 00000022726HL4; 00000025102HL5; 00000024837HL7; 00000025100HL9; 00000025105HL8; 00000024770HL0 and FMITR170990633 (distribution list attached)

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 HUALUN MEDICAL SYSTEMS CO., LTDA..

¿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
    1521
  • Fecha
    2014-12-16
  • 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
    According to the record holder, the problem occurred in an equipment unit. The unit was not in use so no injuries were reported as a result of this problem. The cause of cable breakage after the investigation was performed was fatigue. Rupture of the structure may cause bucky to fall during use of the equipment and possible injury to a patient or operator.
  • Causa
    According to information from the record holder, both the steel wire ropes of the proteus x-ray system's wall bracket rupture, causing the bucky cabinet to fall to the floor.
  • Acción
    According to company information, if you observe any abnormal movement of the wall mount bucky of the Proteus XR / a x-ray imaging system, you should immediately stop using it and contact your local GE Healthcare service representative . (See Customer Letter) The user should also check that the service procedure is up to date. The procedure is available at the link below: http://apps.gehealthcare.com/servlet/ClientServlet?REQ=Enter+Documentation+Library The search instructions are detailed in the consumer letter (page 2).

Device

X-Ray System PROTEUS X / Ra, Hazard Class III, Model 600-0301, Registration: 80071260005, manufac...

Manufacturer

GE Healthcare do Brasil; GE HUALUN MEDICAL SYSTEMS CO., LTDA.