Events

Alerta De Seguridad para USER'S MANUAL FOR ECLIPSE TMR 2000 LASER SYSTEMS. SYSTEM SERIES NUMBERS: 20103, 20106, 20107, 20114, 20119 To 20150 , 2014, 20158 to 20160, 20164, 20165, 20202 to 20204, 20209, 20211, 20230, 20231, 20234, 20250 to 20254, 20260, 20264 to 20268, 20270 to 20273, 20278, 20279, 20283, 20286, 20287 to 20290 , 20293 to 20297, 20303 to 20317, 20319, 20321 to 20327, 20333 to 20487, 40103, 40106, 40107, 40110, 40112 to 40114, 40116.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por TECNOLOGIAS CIRÚRGICAS ECLIPSE INC..

¿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
    10
  • Fecha
    2001-03-14
  • 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
    Laser use manuals violate health law as no longer recommended agenda for maintenance procedures including calibration periodicity.
  • Acción
    THE MANUFACTURER STARTED WITHDRAWAL ON JANUARY 18, 2001. RELEVANT HOSPITALS, CLINICS AND SURGEONS SHOULD VERIFY RECEIPT OF NOTIFICATION AND ECLIPSE URGENT RESPONSE FORM. IMMEDIATELY DISCONTINUE USE OF THIS MANUAL, DISCONTINUE AND REPLACE WITH THE NEW VERSION. COMPLETE THE ECLIPSE URGENT RESPONSE FORM AND RETURN BY FAX 00XX 1 (408) 548-2169. FOR FURTHER INFORMATION, TELEPHONY TO ECLIPSE NO 00XX 1 (408) 465-1121.

Device

USER'S MANUAL FOR ECLIPSE TMR 2000 LASER SYSTEMS. SYSTEM SERIES NUMBERS: 20103, 20106, 20107, 201...

Manufacturer

TECNOLOGIAS CIRÚRGICAS ECLIPSE INC.
  • Source
    ANVSANVISA