Recall Z-0602-2009 ยท FNM Mattress, Air Flotation, Alternating Pressure
Hill-Rom Manufacturing, Inc.
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.
| Date | Jan 7, 2009 (initiated Oct 9, 2008) |
| Status | Terminated |
| Reason | These devices have the potential to overheat. |
| Root cause | Device Design |
| Action | All end users (those who either purchased the device and any customer that has rented) were notified by an Urgent Field Safety Notice on/about 10/31/2008. The letter informed the customers of the safety risk and list steps they can take to mitigate the risk until a Hill-Rom representative is able to modify the device. For the devices that were sold, the consignee of each device was notified by letter for the safety risk and what they can do to mitigate the risk until a Hill-Rom representative is able to modify the device. For the devices that are rented, an internal notification was sent via |
| Quantity | 2,083 units (Total all four units) |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.