Events

Retiro De Equipo (Recall) de Device Recall Aksys PHD Personal Hemodialysis 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 Aksys, Ltd..

¿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
    35723
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1239-06
  • Fecha de inicio del evento
    2006-06-26
  • Fecha de publicación del evento
    2006-07-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-05-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46686
  • 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
    Dialyzer, High Permeability With Or Without Sealed Dialysate System - Product Code KDI
  • Causa
    The hemodialysis device was being marketed with a modified treatment length that exceeds the treatment length for which the device was originally designed.
  • Acción
    Aksys sent a Clinical Bulletin: Field Correction Recall, CB Number: 048, dated 6/26/2006, via overnight Federal Express to all clinics or patients currently using the PHD instrument. CB #048 advises patients that until field modifications to the PHD System can be performed to limit the maximum treatment time to 170 minutes, Aksys recommends that users not exceed this treatment time in the interim. Each user was requested to contact his/her clinic to discuss how this change may affect treatment options and to complete and mail an enclosed pre-paid, self-addressed receipt acknowledgement card. A revised PHD System Operatror''s Manual was issued to all PHD System users on 7/12/06, which reflects the reduction in the maximum treatment time.

Device

Device Recall Aksys PHD Personal Hemodialysis System
  • Modelo / Serial
    Serial numbers A000089, A000093, A000095, A100002, A100003, A100005, A100009, A100016, A100024, A100031, A100042, A100043, A100049, A100066, A100067, A100076, A100077, A100081, A100083, A100084, A100094, C100104, C100107, C100109, C100114, C100116, C100117, C100123, C100124, C100125, C100126, C100127, C100128, C100131, C100132, C100133, C100136, C100139, C100140, C100142, C100143, C100146, C100149, C100151, C100152, C100157, C100161, C100162, C100163, C100164, C100166, C100173, C100174, C100175, C100176, C100178, C100179, C100180, C100181, C100185, C100187, C100188, C100190, C100191, C100192, C100194, C100195, C100198, C100199, C100200, C100201, C100202, C100204, C100206, C100207, C100209, C100211, C100212, C100214, C100217, C100218, C100219, C100222, C100226, C100227, C100228, C100229, C100230, C100232, C100233, C100234, C100236, C100238, C100239, C100240, C100241, C100243, C100244, C100245, C100246, C100247, C100248, C100249, C100251, C100252, C100253, C100254, C100255, C100256, C100257, C100259, C100260, C100263, C100264, C100265, C100266, C100302, C100305, C100306, C100307, C100308, C100310, C100311, C100312, C100314, C100315, C100317, C100318, C100320, C100321, C100326, C100328, C100329.
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide (California, Connecticut, Florida, Georgia, Illinois, Maryland, Massachusetts, Michigan, Ohio, Nebraska, New Jersey, New York, Tennessee, Texas, Virginia, Washington and Wisconsin), and internationally to the United Kingdom.
  • Descripción del producto
    Aksys PHD Personal Hemodialysis System for daily home hemodialysis; an automated high permeability hemodialysis system, water purification system for hemodialysis; Manufactured in the USA for Aksys Ltd., Lincolnshire, IL 60069 USA; Model 1M101
  • Manufacturer
    Aksys, Ltd.

Manufacturer

Aksys, Ltd.
  • Dirección del fabricante
    Aksys, Ltd., 2 Marriott Dr, Lincolnshire IL 60069-3700
  • Source
    USFDA