Device recall
Z-0864-2019: TRINIAS for diagnostic imaging and interventional procedures in cardiac…
FDA device recall · Class II · Shimadzu Medical Systems Usa Com
Key facts
| Recall number (Z-number) | Z-0864-2019 |
|---|---|
| Recall event | 82002 |
| Product | TRINIAS for diagnostic imaging and interventional procedures in 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 30, 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