Events

Retiro De Equipo (Recall) de Device Recall Century Console Base

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 Salyer Prn Biomedical.

¿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
    64383
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0902-2013
  • Fecha de inicio del evento
    2013-01-31
  • Fecha de publicación del evento
    2013-03-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-04-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115964
  • 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
    Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
  • Causa
    Concerns that the addition of the ups battery backup to the century console base shelf did not comply with the fda premarket notification regulations.
  • Acción
    An Urgent: Medical Device Recall letter, dated 1/31/13, was sent to all the customers that received the Century Console Base Shelf option with the Linear/1.5k 115v UPS Battery Backup for the Century Heart Lung Machine. The letter informed the customers that Salyer PRN Biomedical will have a Salyer Biomedical technician return the customers' Century Console Bases to their original configuration without the Shelf option and restore the Linear/1.5k UPS Battery Backup to its original condition as a stand-alone unit with its own wheel base for ease of use. A refund or credit will be issued for the return of the product. Customers are instructed to contact Jeff Poland at (314) 497-5232.

Device

Device Recall Century Console Base
  • Modelo / Serial
    Serial Numbers: CCB40120, CCB40121, CCB40122, CCB40123, CCB40124, CCB40139, CCB40140, CCB40143, and CCB40144.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed in the states of MA,CA, and WI.
  • Descripción del producto
    Century Console Base, Model #043625051b. || Intended for use as a platform for other ancillary equipment and disposable products in cardiopulmonary surgical procedures.
  • Manufacturer
    Salyer Prn Biomedical

Manufacturer

Salyer Prn Biomedical
  • Dirección del fabricante
    Salyer Prn Biomedical, 1833 W Main St Ste 116, Mesa AZ 85201-6924
  • Source
    USFDA