Device recall
Z-2113-2017: PARADYM Models: VR 8250, DR 8550, CRT-D 8750, RF VR 9250, RF DR 9550, RF CRT-D…
FDA device recall · Class II · Sorin Group Italia SRL - CRF
Key facts
| Recall number (Z-number) | Z-2113-2017 |
|---|---|
| Recall event | 77139 |
| Product | PARADYM Models: VR 8250, DR 8550, CRT-D 8750, RF VR 9250, RF DR 9550, RF CRT-D 9750, SonR 8770, RF SonR 9770 Product Usage: OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM RF VR 9250, PARADYM RF DR 9550, INTENSIA VR 124 and INTENSIA DR 154 are indicated for use in patients… |
| Product code | MRM |
| Recalling firm | Sorin Group Italia SRL - CRF |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 22, 2020 |
| PMA numbers | P980049, P980049S050 |
| FEI number | 1000165971 |
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