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
FDA Recall Z-1239-06 · Posted 2006-07-13
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Recalling FirmAksys, Ltd.
Recall StatusTerminated
Product CodeKDI
Date Initiated2006-06-26
Date Terminated2008-05-09
Product Quantity133 units
Reason for Recall
The hemodialysis device was being marketed with a modified treatment length that exceeds the treatment length for which the device was originally designed.
Firm 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.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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