Retiro De Equipo (Recall) de Device Recall Levitronix CentriMag

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 Levitronix, Llc.

¿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
    47409
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1901-2008
  • Fecha de inicio del evento
    2008-03-17
  • Fecha de publicación del evento
    2008-07-23
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2010-07-06
  • 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
    extracorporeal blood circulation system. - Product Code KFM
  • Causa
    Stops pumping: interruption of centrimag system support may occur when using a valleylab force fx-c electrocautery unit.
  • Acción
    Levitronix issued an Urgent - Voluntary Device Correction letter on 3/17/08 mailed to the US distributor and requested to contact their accounts. The letter revises the warning in the CentriMag Console Manual. Levitronix is issuing revised manuals. On March 13, 2008 the firm emailed and mailed (FedEx) to the one Canadian Hospital and Health Canada was informed of the Voluntary Advisory Notice via email on Wednesday, March 19, 2008. Rest of the World: Wednesday, March 12, 2008 through Monday, March 17, 2008. The Notice was issued as a Voluntary Advisory Notice after review and follow up with the UK MHRA. On 7/24/08 the firm issued a revised Recall Letter to advise users not to use Valley Lab Force FX-C or SSE2L Electrosurgery device with the firm's CentriMag Blood Pumping System and include the significant risk to health. The firm revised their letter and Black Box Warning and reissued the letters to the hospital, surgeons, etc. on 7/24/08. On 2/5/09 the firm issued a "Follow-Up to Urgent Device Correction of 3/17/08 " to advise users of the software upgrade to be installed in the CentrigMag Primary software Version 3.0 and CentriMag Back Up console , software version 2.0. Site visits will be made by Levitronix between Feb 2009 and April 2009 , software upgrade installed and new Operating Manuals provided.

Device

  • Modelo / Serial
    All serial numbers
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: USA, Canada, Switzerland, UK, Italy, France, Greece, Spain, Slovenia, Czech, Turkey, South Africa, Argentina, Chile, Panama, Singapore, Taiwan, Israel, and Saudi Arabia.
  • Descripción del producto
    Levitronix CentriMag Back-Up Console || Article Number: 201-30200; extracorporeal blood circulation system.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Levitronix, Llc, 45 1st Ave, Waltham MA 02451-1105
  • Source
    USFDA