Events

Alerta De Seguridad para COMPUTERIZED TOMOGRAPH AQUILION. MODELS: MULTI AQUILION (TSX-101A / 4); AQUILION 16 CFX EDITION (TSX-101A / 8); AQUILION 64 TSX-101A / E and AQUILION 32 TSX-101A / D. SERIAL NUMBERS: HCA0662228; HCA0692325; HCA0712498; HCA0722587; HCA0722590; HCA0732649; HCA0742673; HCA0752696; HCA0782874; HCA07X2929; HCA07X2933; HCA0813065; HCA0823119; HCA0833163; HCA0833172; HCA0863267; HCA0863268 and HCA0792893. Anvisa Registry: 10295030061.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por TOSHIBA MEDICAL DO BRASIL 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
    952
  • Fecha
    2009-02-02
  • 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 Toshiba Medical of Brazil Ltda., When there is a failure in the power supply, the immediate interruption of the x-ray generation occurs, and then the warning message "Abnormal XC Status" is shown to the user. In this way, according to the company, the failure in question does not produce damages to patients and users. If you need to contact the company to handle this case, the contact is as follows: Adriano Bordignom (Technology Manager), Tel. (11) 4134-0063. UTVIG / ANVISA is following up on this case.
  • Causa
    The power supply that controls the x-ray generating unit fails.
  • Acción
    The holder of the product registration informed that he has already begun, on 05/01/2009, the process of correcting the problem - by changing the power supplies of the equipment under risk. To the users of the product it is recommended, if the equipment presents the warning message (ABNORMAL XC STATUS), contact the local technical assistance of Toshiba medical do Brasil Ltda (check the address and telephone number in the Manufacturer's description field.

Device

COMPUTERIZED TOMOGRAPH AQUILION. MODELS: MULTI AQUILION (TSX-101A / 4); AQUILION 16 CFX EDITION (...

Manufacturer

TOSHIBA MEDICAL DO BRASIL LTDA.
  • Empresa matriz del fabricante (2017)
    Canon Inc
  • Source
    ANVSANVISA