Device recall
Z-2051-2014: Shape HF Cardiopulmonary System. Made up of Shape HF System Analyzer (PN…
FDA device recall · Class II · Shape Medical Systems, Inc
Key facts
| Recall number (Z-number) | Z-2051-2014 |
|---|---|
| Recall event | 68581 |
| Product | Shape HF Cardiopulmonary System. Made up of Shape HF System Analyzer (PN 0001-9001) and Disposable Patient Interface (DPI), (PN 0004-4001). A pulmonary gas exchange testing system used during cardiopulmonary exercise testing where collection and review of gas exchange variables are indicated. The… |
| Product code | BTY |
| Recalling firm | Shape Medical Systems, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 22, 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