Events

Rappel de Device Recall Aksys PHD Personal Hemodialysis System

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Aksys, Ltd..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    35723
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1239-06
  • Date de mise en oeuvre de l'événement
    2006-06-26
  • Date de publication de l'événement
    2006-07-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-05-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46686
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Dialyzer, High Permeability With Or Without Sealed Dialysate System - Product Code KDI
  • Cause
    The hemodialysis device was being marketed with a modified treatment length that exceeds the treatment length for which the device was originally designed.
  • Action
    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
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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.
  • Adresse du fabricant
    Aksys, Ltd., 2 Marriott Dr, Lincolnshire IL 60069-3700
  • Source
    USFDA