Device recall
Z-0614-2018: Artis oneFloor-mounted system for uncompromised imaging; Artis one…
FDA device recall · Class II · Siemens Medical Solutions USA, INC
Key facts
| Recall number (Z-number) | Z-0614-2018 |
|---|---|
| Recall event | 78963 |
| Product | Artis oneFloor-mounted system for uncompromised imaging; Artis one, Interventional fluoroscopic x-ray system, Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. X-ray generator POLYDOROS A100… |
| Product code | OWB |
| Recalling firm | Siemens Medical Solutions USA, INC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 21, 2018 |
| 510(k) numbers | K133580 |
| 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