Events

Alerta De Seguridad para Vision Model T-22 Gamma Camera System. Series nº: 1 to 50.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por GE Medical System; Hitachi Medical Corp.

¿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
    388
  • Fecha
    2002-02-15
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    The pin of the collimator in the above system may fall and cause the collimator to collapse, which may result in injury. the dealer initiated a correction by letter dated august 27, 2001.
  • Acción
    Make sure you received the letter dated August 27, 2001 from GE Medical Systems. You will be contacted by GE's engineering services, who will schedule a visit to reset the collimator pin of the affected product. If you have not yet been contacted by the engineering service, or for more information, contact your local GE Medical Systems representative. ANVISA has provided the Occurrence Notification Forms on the Internet www.anvisa.gov.br/tecnovigilancia to notify you if you encounter any problems with the products in your inventory. For more information, contact the ANVISA Technovigilance Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485.

Device

Vision Model T-22 Gamma Camera System. Series nº: 1 to 50.

Manufacturer

GE Medical System; Hitachi Medical Corp
  • Source
    ANVSANVISA