Device recall
Z-0554-2021: Bransist Safire, Digital Angiography System containing a MS-200 Ceiling…
FDA device recall · Class II · Shimadzu Medical Systems
Key facts
| Recall number (Z-number) | Z-0554-2021 |
|---|---|
| Recall event | 86846 |
| Product | Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspended C-arm Support - Product Usage: designed to provide fluoroscopic images of the patient during diagnostic surgical and interventional angiography and cardiology procedures. |
| Product code | IZI |
| Recalling firm | Shimadzu Medical Systems |
| Recall class | Class II |
| Status | Open, Classified |
| 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