Retiro De Equipo (Recall) de Device Recall Electrosurgical generator.

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por ConMed Electrosurgery.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    57544
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1365-2011
  • Fecha de inicio del evento
    2010-12-27
  • Fecha de publicación del evento
    2011-02-17
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2011-08-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Causa
    Electrosurgical generator may allow possibility of electrical shock and/or burns to user or patient.
  • Acción
    ConMed Electrosurgery sent an Urgent Device Recall letter dted December 27, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to notify anyone who may have received the affected product.. They were to review their inventory and return a Business Reply Form via fax to 303-699-9854 and to contact ConMed Electrosurgery Technical Services at 800-552-0138 to schedule a time to have their equipment upgraded.

Device

  • Modelo / Serial
    Serial numbers: 05KGU013, 06CGU036, 06CGU001, 06CGU034, 06CGU035,  06CGU037, 06CGU038, 06CGU039, 06CGU040, 06CGU042, 06CGU043,  06CGU044, 06CGU045, 06CGU046, 06CGU047, 06CGU048, 06CGU049,  06CGU050, 06CGU051, 06CGU052, 06CGU053, 06CGU054, 06CGU055,  06CGU056, 06CGU057, 06CGU058, 06CGU059, 06DGU061, 06DGU062,  06DGU063, 06DGU064, 06DGU065, 06DGU066, 06DGU067, 06DGU068,  06DGU069, 06EGU081, 06EGU082, 06EGU083, 06EGU084, 06EGU085,  06EGU086, 06EGU087, 06EGU088, 06EGU089, 06EGU090, 06EGU091,  06EGU092, 06EGU093, 06EGU094, 06EGU095, 06EGU096, 06EGU097,  06EGU098, 06EGU099, 06EGU100, 06FGU081, 06FGU084, 06FGU085,  06FGU086, 06FGU087, 06FGU088, 06FGU089, 06FGU090, 06LGU001,  06LGU002, 06LGU003, 06LGU004, 06LGU005, 06LGU006, 06LGU007,  06LGU010, 06LGU008, 06LGU009, 06MGU026, 06MGU027, 06MGU028,  06MGU029, 06MGU030, 06MGU031, 06MGU032, 06MGU033, 06MGU034,  06MGU035, 07AGU031, 07AGU032, 07AGU033, 07AGU034, 07AGU035,  07AGU036, 07AGU037, 07AGU038, 07AGU039, 07AGU040, 07AGU041,  07AGU042, 07AGU043, 07AGU044, 07AGU045, 07AGU046, 07AGU047,  07AGU048, 07AGU049, 07HGU052, 07FGU071, 07FGU072, 07FGU073,  07FGU074, 07FGU075, 07FGU076, 07FGU077, 07FGU078, 07FGU079,  07FGU080, 07GGU001, 07GGU002, 07GGU003, 07GGU004, 07GGU005,  07GGU006, 07GGU007, 07GGU008, 07GGU009, 07GGU010, 07HGU051,  07HGU053, 07HGU054, 07HGU055, 07HGU056, 07HGU057, 07HGU058,  07HGU059, 07HGU060, 07HGU061, 07HGU062, 07HGU063, 07HGU064,  07HGU065, 07HGU066, 07HGU067, 07HGU068, 07HGU069, 07HGU070,  07HGU071, 07HGU073, 07JGU051, 07JGU052, 07JGU053, 07JGU054,  07JGU055, 07JGU056, 07JGU057, 07KGU021, 07KGU022, 07KGU023,  07KGU024, 07KGU025, 07KGU026, 07KGU027, 07KGU028, 07KGU029,  07KGU030, 07KGU031, 07KGU032, 07KGU033, 07KGU034, 07KGU035,  07KGU036, 07KGU037, 07KGU038, 07KGU039, 07LGU011, 07LGU012,  07LGU013, 07LGU014, 07LGU015, 07LGU016, 07LGU017, 07LGU018,  07LGU019, 07LGU020, 07MGU021, 07MGU022, 07MGU023, 07MGU024,  07MGU025, 07MGU026, 07MGU028, 07MGU029, 07MGU030, 08AGU051,  08AGU052, 08AGU053, 08AGU054, 08AGU055, 08AGU056, 08AGU057,  08AGU058, 08AGU059, 08AGU060, 08BGU001, 08BGU002, 08BGU003,  08BGU004, 08BGU005, 08BGU006, 08BGU007, 08BGU008, 08BGU009,  08BGU010, 08BGU011, 08BGU012, 08BGU013, 08BGU014, 08BGU015,  08CGU046, 08CGU047, 08CGU048, 08CGU049, 08CGU050, 08CGU051,  08CGU052, 08CGU053, 08CGU054, 08CGU055, 08CGU056, 08CGU057,  08CGU058, 08CGU059, 08CGU060, 08CGU091, 08CGU092, 08CGU093,  08CGU094, 08CGU095, 08CGU096, 08CGU097, 08CGU098, 08CGU099,  08DGU061, 08DGU062, 08DGU063, 08DGU064, 08DGU065, 08DGU066,  08DGU067, 08DGU068, 08DGU069, 08DGU070, 08DGU071, 08DGU072,  08DGU073, 08DGU074, 08DGU075, 08DGU076, 08DGU077, 08DGU078,  08EGU071, 08EGU072, 08EGU073, 08FGU062, 08FGU063, 08FGU064,  08FGU065, 08FGU066, 08FGU067, 08FGU069, 08FGU070, 08FGU071,  08FGU072, 08FGU073, 08FGU074, 08FGU075, 08FGU076, 08FGU077,  08FGU078, 08FGU079, 08FGU080, 08GGU091, 08GGU092, 08GGU093,  08GGU094, 08GGU095, 08GGU096, 08GGU097, 08GGU098, 08GGU099,  08GGU100, 08HGU061, 08HGU062, 08HGU063, 08HGU064, 08HGU065,  08HGU066, 08HGU067, 08HGU068, 08HGU069, 08HGU070, 08HGU071,  08HGU072, 08JGU061, 08JGU062, 08JGU063, 08JGU064, 08JGU065,  08KGU061, 08KGU062, 08KGU063, 08KGU064, 08KGU065, 08KGU066,  08KGU067, 08KGU068, 08KGU069, 08KGU070, 09KGU072, 08KGU091,  08KGU092, 08KGU093, 08KGU094, 08KGU095, 08KGU096, 08KGU097,  08KGU098, 08KGU099, 08KGU100, 08MGU061, 08MGU062, 08MGU063,  08MGU064, 08MGU065, 08MGU066, 08MGU067, 08MGU068, 08MGU069,  08MGU070, 08MGU071, 08MGU072, 08MGU073, 08MGU074, 08MGU075,  09AGU061, 09AGU062, 09AGU063, 09AGU064, 09AGU065, 09AGU066,  09AGU067, 09AGU068, 09AGU069, 09AGU071, 09AGU072, 09AGU074,  09AGU075, 09AGU076, 09AGU73, 09BGU061, 09BGU062, 09BGU063,  09BGU064, 09BGU065, 09CGU076, 09CGU077, 09CGU078, 09CGU079,  09CGU080, 09CGU081, 09CGU082, 09CGU083, 09CGU084, 09CGU085,  09CGU086, 09CGU087, 09CGU088, 09CGU089, 09CGU090, 09CGU091,  09CGU092, 09CGU093, 09CGU094, 09CGU095, 09CGU111, 09CGU112,  09CGU113, 09CGU114, 09DGU061, 09DGU062, 09DGU063, 09DGU064,  09DGU066, 09DGU067, 09DGU068, 09DGU069, 09DGU070, 09DGU071,  09DGU072, 09DGU073, 09DGU074, 09DGU075, 09DGU076, 09DGU077,  09DGU078, 09DGU079, 09DGU080, 09DGU101, 09DGU102, 09DGU103,  09DGU104, 09GGU084, 09GGU081, 09GGU083, 09GGU085, 09GGU086,  09GGU087, 09GGU088, 09GGU089, 09GGU090, 09GGU091, 09GGU092, 09GGU093, 09GGU094, 09GGU095, 09GGU096, 09GGU097, 09GGU098,  09GGU100, 09GGU102, 09GGU103, 09GGU104, 09GGU105, 09GGU106,  09GGU107, 09GGU108, 09GGU109, 09GGU110, 09GGU111, 09GGU112,  09GGU113, 09GGU114, 09GGU115, 09GGU116, 09GGU117.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution, including USA (nationwide) and the countries of Australia, Belgium, Bolivia, Canada, Chile, China, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Honduras, Hong Kong, Hungary, India, Iraq, Israel, Italy, Jamaica, Japan, Jordan, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Puerto Rico, Qatar, Romania, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, Uruguay, Venezuela, Vietnam.
  • Descripción del producto
    ConMed System 2450 Electrosurgical Generator, REF 60-2450-230, 230V-240V, ConMed Electrosurgery, Centennial, CO. || A general-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of high (HF) electrosurgical current through an accessory electrode for cutting and coagulation at the operative site.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    ConMed Electrosurgery, 14603 E Fremont Ave, Centennial CO 80112-4251
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA