Pro 2000, Alternating Pressure Air Flotation Mattress, Model number 5613 Designed to provide enhanced static and pulsation pressure relieving therapies.
Recall
- Recall Number
- Z-0603-2009
- Event Number
- 50144
- Firm
- Hill-Rom Manufacturing, Inc.
- FEI Number
- 1045510
- Product Code
- FNM
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- October 9, 2008
- Posted
- January 7, 2009
- Terminated
- December 10, 2009
- Address
- 4349 Corporate Rd, Charleston, SC, 29405-7445
Description
Pro 2000, Alternating Pressure Air Flotation Mattress, Model number 5613 Designed to provide enhanced static and pulsation pressure relieving therapies.
These devices have the potential to overheat.
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.
Nationwide Distribution.
2,083 units (Total all four units)