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U.S. Department of Health and Human Services

Class 2 Device Recall Synergy Air Squared

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  Class 2 Device Recall Synergy Air Squared see related information
Date Initiated by Firm October 09, 2008
Date Posted January 07, 2009
Recall Status1 Terminated 3 on December 10, 2009
Recall Number Z-0602-2009
Recall Event ID 50144
Product Classification Alternating Pressure Air Flotation Mattress - Product Code FNM
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.
Code Information All serial numbers
Recalling Firm/
Hill-Rom Manufacturing, Inc.
4349 Corporate Rd
Charleston SC 29405-7445
For Additional Information Contact Joe Fogel
Manufacturer Reason
for Recall
These devices have the potential to overheat.
FDA Determined
Cause 2
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 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.
Quantity in Commerce 2,083 units (Total all four units)
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.