Device recall
Z-2591-2020: Trinias DAP Meter, a component of the Digital Anglo System Trinias contained…
FDA device recall · Class II · Shimadzu Medical Systems
Key facts
| Recall number (Z-number) | Z-2591-2020 |
|---|---|
| Recall event | 85416 |
| Product | Trinias DAP Meter, a component of the Digital Anglo System Trinias contained within the DAR-9500f - Product Usage: It is intended to be used for interventional procedures, such as invasive cardiology, interventional radiology, and interventional neuroradiology. |
| Product code | OWB |
| Recalling firm | Shimadzu Medical Systems |
| Recall class | Class II |
| Status | Completed |
| 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