Device recall
Z-1813-2010: System 98XT/98 Intra-Aortic Balloon Pump This product was only distributed in…
FDA device recall · Class II · Datascope Corporation
Key facts
| Recall number (Z-number) | Z-1813-2010 |
|---|---|
| Recall event | 55649 |
| Product | System 98XT/98 Intra-Aortic Balloon Pump This product was only distributed in India and Hong Kong/China. |
| Product code | DSP |
| Recalling firm | Datascope Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 27, 2010 |
| FEI number | 1000222374 |
At a glance
- None 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