Device recall
Z-0959-2019: BRANSIST safire Product Usage: DIGITAL ANGIOGRAPHY SYSTEM This system is…
FDA device recall · Class II · Shimadzu Medical Systems Usa Com
Key facts
| Recall number (Z-number) | Z-0959-2019 |
|---|---|
| Recall event | 81981 |
| Product | BRANSIST safire Product Usage: DIGITAL ANGIOGRAPHY SYSTEM This system is intended to be used for radiologic visualization of the heart, blood vessels or lymphatic system during or after injection of a contrast medium. It is to be used in the diagnosis of the circulatory vascular system while being… |
| Product code | IZI |
| Recalling firm | Shimadzu Medical Systems Usa Com |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 7, 2024 |
| 510(k) numbers | K062360 |
| 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