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.
- Company
- Hill-Rom Manufacturing, Inc.
- Recall Initiated
- October 9, 2008
- Posted
- January 7, 2009
- Terminated
- December 10, 2009
- Recall Number
- Z-0602-2009
- Quantity
- 2,083 units (Total all four units)
- Firm Location
- Charleston, SC
Reason for Recall
These devices have the potential to overheat.
Distribution
Nationwide Distribution.
Lot / Code Info
All serial numbers
Root Cause
Device Design
Action Taken
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 e-mail to Service Centers (Because the device is owned by the manufacturer, Hill-Rom, each Service Center in possession of the device will be the Consignee). Each Service Center will perform the correction on the units affected.