BEUDAMED
    FDA Recall Terminated

    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

    Recall: Z-1239-06 · Initiated June 26, 2006

    Recall

    Recall Number
    Z-1239-06
    Event Number
    35723
    Firm
    Aksys, Ltd.
    FEI Number
    3000265533
    Product Code
    KDI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 26, 2006
    Posted
    July 13, 2006
    Terminated
    May 9, 2008
    Address
    2 Marriott Dr, Lincolnshire, IL, 60069-3700

    Description

    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

    Reason

    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.

    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.

    Quantity

    133 units