FDA-Device2013-08-21Class II
IsoGel AIR 84, Support Surface. Intended to assist in improving human patient outcomes.
Stryker Medical Division of Stryker Corporation
Hazard
Complaints were received from the field indicating that some Air Pumps were flashing and alarming when connected to the IsoGel AIR" surface upon turning the pump on and the setting it to the IsoGel AIR Mode. Upon further investigation, it was determined that the flashing/alarm being experienced was due to the air pressure being out of the expected range; indicating a blockage within the LAL tubi
Sold states
Nationwide Distribution-USA including the states of OH, ME, IL, CO , FL, TX, MI, GA, and VA.
Affected count
586 units
Manufactured in
3800 E Centre Ave, Portage, MI, United States
Products
IsoGel AIR 84, Support Surface. Intended to assist in improving human patient outcomes.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1946-2013Don't want to check this manually?
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