Device recall
Z-0399-2024: ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic…
FDA device recall · Class II · LEONI CIA CABLE SYSTEMS
Key facts
| Recall number (Z-number) | Z-0399-2024 |
|---|---|
| Recall event | 93315 |
| Product | ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00009 |
| Product code | JAI |
| Recalling firm | LEONI CIA CABLE SYSTEMS |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K160518 |
| FEI number | 3012834372 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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