Events

Retiro De Equipo (Recall) de Device Recall Esaote GScan Brio

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 Esaote S.p.A..

¿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
    74391
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2124-2016
  • Fecha de inicio del evento
    2016-06-06
  • Fecha de publicación del evento
    2016-07-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-05-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147902
  • 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
    System, nuclear magnetic resonance imaging - Product Code LNH
  • Causa
    The device is being recalled because dynamic loading forces from larger patients can fracture the extremity portion of the patient table. additionally, a weight limit is added to the patient seat for weight-bearing examinations.
  • Acción
    Esaote initiated a voluntary recall of the G-scan Brio Magnetic Resonance System on 06/06/2016 with letters sent via certified, due to a potential weakness on the extremity areas of the patient table that could lead to a stress fracture of the table. The firm has instructed customers to refer to the Medical Device Safety Notification provided with the recall notice, date and sign this letter in the space provided on the last page and send it back via email to quality@esaoteusa.com. If customers have questions regarding the recall, please call 1-317-813-6030. For additional information, please contact us by phone during normal business hours, Monday-Friday from 8:00am  5:00pm Eastern Standard Time, via email at quality@esaoteusa.com, or at any time by visiting our website. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online at www.fda.gov/medwatch/report.htm, by regular mail using the postage-paid, pre-addressed Form FDA3500 available at www.fda.gov/MedWatchgetforms.htm or by fax to 1-800-FDA-0178.

Device

Device Recall Esaote GScan Brio
  • Modelo / Serial
    Item No., Unit Description and Serial No.s: 101002000, UNIT, G-SCAN BRIO, 05202; 101002000, UNIT, G-SCAN BRIO, 05203; 101002000, UNIT, G-SCAN BRIO 2.1A; 05205; 101002000, UNIT, G-SCAN BRIO 2.1A, 05207; 101002000 UNIT, G-SCAN BRIO 2.1A, 05208; 101002000 UNIT, G-SCAN BRIO 2.1A, 05209; 101002000 UNIT, G-SCAN BRIO 2.1A, 05210; 101002000 UNIT, G-SCAN BRIO 2.1A, 05211; 101002000 UNIT, G-SCAN BRIO 2.1A, 05305; 101002000 UNIT, G-SCAN BRIO 2.1A, 05308
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Domestic: FL, TX, OH, MN, NV; Foreign: No customers in Canada; No VA/DOD.
  • Descripción del producto
    Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000)
  • Manufacturer
    Esaote S.p.A.

Manufacturer

Esaote S.p.A.