Device recall
Z-1239-06: Aksys PHD Personal Hemodialysis System for daily home hemodialysis; an automated…
FDA device recall · Class II · Aksys, Ltd.
Key facts
| Recall number (Z-number) | Z-1239-06 |
|---|---|
| Recall event | 35723 |
| 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 |
| Product code | KDI |
| Recalling firm | Aksys, Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 9, 2008 |
| 510(k) numbers | K010131 |
| FEI number | 3000265533 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database