Events

Retiro De Equipo (Recall) de Device Recall ConMed ALTRUS Thermal Tissue Fusion System

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 Corporation.

¿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
    72586
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0359-2016
  • Fecha de inicio del evento
    2015-11-05
  • Fecha de publicación del evento
    2015-12-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-05-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141613
  • 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
    Miscalibration of the energy source monitoring function, which may incorrectly sense the handpiece temperature as higher than the actual handpiece's temperature. this causes some devices to generate a "check seal" message with an audible alarm and to stop the heating cycle.
  • Acción
    On November 4, 2015, ConMed Corporation distributed Urgent Device Recall Notification letters dated November 5, 2015 to their customers via overnight courier service. Customers should stop the use of these devices immediately. The recall notice recipient should contact all organizations within their facility and any other facilities that may have received the affected products. It is imperative that all end users of these devices receive this notice and respond immediately. Customers with questions can call Patricia Cotter, ConMed Recall Coordinator 315-624-3237 (8AM - 5PM EST, Monday through Friday), or fax to 315-624-3225 or email altrus@conmed.com. Customers who have any of the devices subject to recall (listed on the recall notice-attachment I) should immediately contact their sales representative. The sales representative will deliver a replacement unit to your facility and will pick up and return the recalled devices to ConMed Corporation. If you are unable to reach your sales representative, please contact Patricia Cotter at the numbers above. If you do not have any devices to return, customers should complete the Business Reply Form (attachment II), indicating you have no devivces and fax it to 315-624-3225, Attn: Patricia Cotter.

Device

Device Recall ConMed ALTRUS Thermal Tissue Fusion System
  • Modelo / Serial
    Serial Numbers: 1) 15090103 & 15150005, 15150006, 15150007, 15150008, 15150009, 15150010, 15150011, 15150012, 15130004, 15250013, 15250014, 15250015, 15250016, 15250017, 15300018 & 15300020, 2) 15050001, 15300005 & 15300006
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed in the states of CA, and TX and in the country of Mexico.
  • Descripción del producto
    Altrus Thermal Tissue Fusion Energy Sources, Catalog Numbers: 1) 60-9500-120 & 2) 60-9500-INT. Thermal Ligation and Cutting Energy Source.
  • Manufacturer
    ConMed Corporation

Manufacturer

ConMed Corporation
  • Dirección del fabricante
    ConMed Corporation, 525 French Rd, Utica NY 13502-5945
  • Empresa matriz del fabricante (2017)
    CONMED Corp.
  • Source
    USFDA