Device recall
Z-0602-2009: Synergy Air Squared, Alternating Pressure Air Flotation Mattress, Model number…
FDA device recall · Class II · Hill-Rom Manufacturing, Inc.
Key facts
| Recall number (Z-number) | Z-0602-2009 |
|---|---|
| Recall event | 50144 |
| Product | Synergy Air Squared, Alternating Pressure Air Flotation Mattress, Model number 6361. Designed to prevent and treat decubitus ulcers. This is accomplished by achieving interface pressures well below capillary closure during the alternation cycle. |
| Product code | FNM |
| Recalling firm | Hill-Rom Manufacturing, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 10, 2009 |
| FEI number | 1045510 |
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