International Medical Devices Database

Manufacturer Address
Aksys, Ltd., 2 Marriott Dr, Lincolnshire IL 60069-3700
Source
USFDA
1 Event
- Recall of Device Recall Aksys PHD Personal Hemodialysis System

One device in the database

Device Recall Aksys PHD Personal Hemodialysis System

Model / 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.
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
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.
Product 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

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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Aksys, Ltd.

One device in the database

Device Recall Aksys PHD Personal Hemodialysis System