Device recall
Z-1496-2020: Artis Q.zen Biplane, Model No. 10848355 Artis Q.zen Ceiling, Model No. 10848354…
FDA device recall · Class II · Siemens Medical Solutions USA, Inc
Key facts
| Recall number (Z-number) | Z-1496-2020 |
|---|---|
| Recall event | 85071 |
| Product | Artis Q.zen Biplane, Model No. 10848355 Artis Q.zen Ceiling, Model No. 10848354 Artis Q.zen Floor, Model No. 10848353 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to… |
| Product code | OWB |
| Recalling firm | Siemens Medical Solutions USA, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 20, 2021 |
| 510(k) numbers | K181407 |
| FEI number | 2240869 |
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