Aksys, Ltd.
Country not established
- Devices
- 1
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Aksys, Ltd. makes
Aksys, Ltd. manufactures components and accessories for personal hemodialysis systems, including the PHD Personal Hemodialysis Instrument, water pre-treatment kits, hard plumbing kits, and blood tubing.
These devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Aksys, Ltd., initiated on 2006-06-26. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2006
- 26 Jun 2006 Z-1239-06 Unclassified (pre-2012) Terminated The hemodialysis device was being marketed with a modified treatment length that exceeds the treatment length for which the device was originally designed.
Full distribution text
- 26 Jun 2006 Z-1239-06 Unclassified (pre-2012) Terminated The hemodialysis device was being marketed with a modified treatment length that exceeds the treatment length for which the device was originally designed.
Frequently asked questions
How many devices does Aksys, Ltd. have in the registry?
The registry currently lists 1 device for Aksys, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Aksys, Ltd.'s devices?
Among its 1 most recently registered device, Aksys, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Aksys, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Aksys, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Aksys, Ltd.?
FDA recall records list 1 recall initiated by Aksys, Ltd., the most recent initiated on 26 Jun 2006. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Aksys, Ltd. in the registry?
The most recently registered devices listed for Aksys, Ltd. include PHD PERSONAL HEMODIALYSIS INSTRUMENT-1M101, PHD WATER PRE-TREATMENT KIT-1W605, PHD HARD PLUMBING KIT-1W604, PHD BLOOD TUB.