Device recall
Z-2537-2018: Patient Positioning System with KRC2 controller using software versions 2.3.1…
FDA device recall · Class II · Forte Automation Systems Inc
Key facts
| Recall number (Z-number) | Z-2537-2018 |
|---|---|
| Recall event | 80510 |
| Product | Patient Positioning System with KRC2 controller using software versions 2.3.1 2.3.10 Product Usage: The patient positioning system is a SCARA designed robotic arm designed to position a patient for medical procedures prescribed by oncologists and others that require a high degree of accuracy and… |
| Product code | JAI |
| Recalling firm | Forte Automation Systems Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 13, 2020 |
| 510(k) numbers | K122413 |
| FEI number | 3003900998 |
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