Device recall
Z-0926-2014: The Rotoprone therapy System is an advanced patient care system for the…
FDA device recall · Class II · ArjoHuntleigh Inc.
Key facts
| Recall number (Z-number) | Z-0926-2014 |
|---|---|
| Recall event | 67248 |
| Product | The Rotoprone therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications. The Rotoprone Therapy System provides up to 62 degrees in both prone and supine positions as well as Trendelenburg/Reverse Trendelenburg positioning. Product Usage: Use of the… |
| Product code | IKZ |
| Recalling firm | ArjoHuntleigh Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 8, 2015 |
| FEI number | 3010048749 |
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