Synergy Air Squared, Alternating Pressure Air Flotation Mattress, Model number 6361. Designed to prevent and treat decub

FDA device recall Z-0602-2009 · posted 2009-01-07 · Terminated

Recall details

Recalling firm

Hill-Rom Manufacturing, Inc.

Reason for recall

These devices have the potential to overheat.

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.

Root cause

Device Design

Status

Terminated

Product code

FNM

Quantity affected

2,083 units (Total all four units)

Distribution

Nationwide Distribution.

Date initiated

2008-10-09

Date posted

2009-01-07

Date terminated

2009-12-10

Location

Charleston, SC