Events

Retiro De Equipo (Recall) de Device Recall 1500T14 Cardiac Ablation System Remote Control

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 St Jude Medical.

¿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
    58859
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2632-2011
  • Fecha de inicio del evento
    2011-05-09
  • Fecha de publicación del evento
    2011-06-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100434
  • 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
  • Causa
    The recall was initiated because st. jude medical has confirmed its t14 and t12 rf generator may malfunction upon encountering an unexpected electric current (e.G. static electricity). the resulting 'malfunction results in a failure of the generator to respond to key presses properly, and may cause unexpected energy delivery or inability to discontinue energy delivery with the start/ stop butt.
  • Acción
    The firm, St. Jude Medical (SJM), sent a "Product Correction" letter dated May 9, 2011 to it's affected customers. The letter described the product, problem and actions to be taken. The customers were instructed to discontinue use of the T14/T12 generators and remote controls until the units have been properly serviced; complete and return the attached field action form, and utilize the units in accordance with the Operators Manual. In case of system malfunction, the customers were instructed to shut off the RF power delivery by turning off the generator via the rocker switch, dislodging the power cord, or disconnecting of the patient cable or indifferent electrode connection. An SJM sales representative will contact the customers in the near future to facilitate repair or exchange of the impacted unit. If you have questions regarding this notice, contact the Marketing Manager, AF at (905-286-4015), Marketing Director, AF/CRM, at (905-286-4107); Product Manager (Tokyo) 03-6255-5740, and/or your SJM sales representative.

Device

Device Recall 1500T14 Cardiac Ablation System Remote Control
  • Modelo / Serial
    Serial Number: 13615332, 13615330, 13615328, 13615331
  • Distribución
    International distribution only: Canada and Japan.
  • Descripción del producto
    1500T14 Cardiac Ablation System - Remote Control || The 1500Tl4 Remote Control can control and operate the 1500Tl4 RF generator remotely via a connecting cable. It has a duplicate front panel controls and displays as of the generator's front panel, with the addition of an optical encoder knob which is used to select and changes the parameters.
  • Manufacturer
    St Jude Medical

Manufacturer

St Jude Medical
  • Dirección del fabricante
    St Jude Medical, One St Jude Medical Dr, Saint Paul MN 55117
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA