Z-0602-2009

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

Name: Z-0602-2009 Synergy Air Squared, Alternating Pressure Air Flotation Mattress, Model number 6361. Designed to prevent and...
Creator: Hill-Rom Manufacturing, Inc.
Published: 2008-10-09
License: https://open.fda.gov/license/

Hill-Rom Manufacturing, Inc. / initiated 2008-10-09 / Terminated / root cause: design

FDA source

Hill-Rom Manufacturing, Inc. began a recall of Synergy Air Squared, Alternating Pressure Air Flotation Mattress, Model number 6361. Designed to prevent and treat decubitus ulcers. This is accomplished by... on 2008-10-09. The reason FDA records is "These devices have the potential to overheat". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0602-2009
Status: Terminated
Initiated: 2008-10-09
Posted: 2009-01-07
Terminated: 2009-12-10
Recalling firm: Hill-Rom Manufacturing, Inc.
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.
Product code: FNM Mattress, Air Flotation, Alternating Pressure
Reason for recall: These devices have the potential to overheat.
Root cause tag: design
FDA 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 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.
Product codes and lots: All serial numbers

Product code FNM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)