Device recall
Z-1060-2015: Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part…
FDA device recall · Class II · Shape Medical Systems, Inc
Key facts
| Recall number (Z-number) | Z-1060-2015 |
|---|---|
| Recall event | 70149 |
| Product | Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number 0004-4001. The Shape-HF Cardiopulmonary Exercise Testing System is a stationary device that monitors parameters during laboratory or clinical conditions. |
| Product code | BTY |
| Recalling firm | Shape Medical Systems, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 14, 2015 |
| 510(k) numbers | K090722 |
| FEI number | 3008072932 |
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