Device recall
Z-0844-2018: INFX-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM
FDA device recall · Class II · Toshiba American Medical Systems Inc
Key facts
| Recall number (Z-number) | Z-0844-2018 |
|---|---|
| Recall event | 79153 |
| Product | INFX-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM |
| Product code | OWB |
| Recalling firm | Toshiba American Medical Systems Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 29, 2023 |
| 510(k) numbers | K133535 |
| 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