Device recall
Z-2609-2011: Paradym DR Model 8550 and Paradym VR Model 8250, Sterile EO, Manufactured in…
FDA device recall · Class II · ela Medical Llc
Key facts
| Recall number (Z-number) | Z-2609-2011 |
|---|---|
| Recall event | 58767 |
| Product | Paradym DR Model 8550 and Paradym VR Model 8250, Sterile EO, Manufactured in Italy by Sorin CRM S. r.l., Via Crescentino s.n., 13040 Saluggia(VC) Italy PARADYM DR 8550 and PARADYM VR 8250 are indicated for use in patients who are at high risk of sudden cardiac death due to ventricular… |
| Product code | MRM |
| Recalling firm | ela Medical Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 26, 2012 |
| PMA numbers | P980049, P980049S050 |
| FEI number | 2182863 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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