Device recall
Z-1217-2015: Rotoprone Therapy System. The Rotoprone Therapy System is an advanced patient…
FDA device recall · Class II · Arjo Hospital Equipment AB
Key facts
| Recall number (Z-number) | Z-1217-2015 |
|---|---|
| Recall event | 69970 |
| Product | Rotoprone Therapy System. The Rotoprone Therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications. |
| Product code | IKZ |
| Recalling firm | Arjo Hospital Equipment AB |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 30, 2015 |
| FEI number | 3002806395 |
At a glance
- None 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