Device recall
Z-0611-2011: RotoProne Therapy System, Model 209500, Device List Number E232632 Product is…
FDA device recall · Class II · KCI USA, Inc.
Key facts
| Recall number (Z-number) | Z-0611-2011 |
|---|---|
| Recall event | 56849 |
| Product | RotoProne Therapy System, Model 209500, Device List Number E232632 Product is designed to allow patients to be mechanically rotated to the prone position and provides kinetic therapy to patients. It is intended for the treatment and prevention of pulmonary complications associated with immobility. |
| Product code | IKZ |
| Recalling firm | KCI USA, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 21, 2011 |
| FEI number | 1625774 |
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