Device recall
Z-0197-2019: TRINIAS Digital Angiographic System intended to be used for cardiac angiography…
FDA device recall · Class II · Shimadzu Medical Systems Usa Com
Key facts
| Recall number (Z-number) | Z-0197-2019 |
|---|---|
| Recall event | 81080 |
| Product | TRINIAS Digital Angiographic System intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures. |
| Product code | OWB |
| Recalling firm | Shimadzu Medical Systems Usa Com |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 28, 2021 |
| 510(k) numbers | K123508 |
| FEI number | 1000125362 |
At a glance
- 1–9 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