Device recall
Z-1295-2015: Transonic Hemodialysis Monitor, Model HD03 -- Product Usage: The Hemodialysis…
FDA device recall · Class II · Transonic Systems Inc
Key facts
| Recall number (Z-number) | Z-1295-2015 |
|---|---|
| Recall event | 70647 |
| Product | Transonic Hemodialysis Monitor, Model HD03 -- Product Usage: The Hemodialysis Monitor is intended for use by trained medical personnel to measure delivered blood flow, vascular access recirculation, vascular access blood flow and cardiac output on patients receiving hemodialysis treatment. |
| Product code | MQS |
| Recalling firm | Transonic Systems Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 31, 2016 |
| 510(k) numbers | K960817 |
| FEI number | 1319030 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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