Aksys, Ltd. 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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Aksys, Ltd.
Lot Codes / Batch Numbers
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.
Products Sold
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.
Aksys, Ltd. is recalling Aksys PHD Personal Hemodialysis System for daily home hemodialysis; an automated high permeability h due to The hemodialysis device was being marketed with a modified treatment length that exceeds the treatment length for which the device was originally desi. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The hemodialysis device was being marketed with a modified treatment length that exceeds the treatment length for which the device was originally designed.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026