Device recall
Z-1394-2015: INFX-8000V Interventional Angiography System. CAT-880B catheterization table…
FDA device recall · Class II · Toshiba American Medical Systems Inc
Key facts
| Recall number (Z-number) | Z-1394-2015 |
|---|---|
| Recall event | 70748 |
| Product | INFX-8000V Interventional Angiography System. CAT-880B catheterization table. Cardiac and Vascular intervention with fluoroscopic and fluorographic images. For the USA and Canada the system is registered as lnfinix CF-i or lnfinix VF-i, for national regulations. INFX-8000V series includes a floor… |
| Product code | OWB |
| Recalling firm | Toshiba American Medical Systems Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 18, 2015 |
| 510(k) numbers | K143225 |
| FEI number | 2020563 |
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