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Draeger Medical Systems, Inc. recalls Draeger Infinity Acute Care System Monitoring Solution
Recalled January 22, 2014 · FDA recall Z-0714-2014 · Draeger Medical Systems
Hazard
After a test in which a low SpO2 (yellow) medium grade alarm initiated in neo-natal mode and was subsequently paused, the high grade life threatening SpO2 alarm (red) did not activate when the SpO2 values were decreased to reach the red alarm limit. · FDA Class II
Units
439
Sold at
US Distribution including the states of: MA, NH, IN, CA, TX, NY, OK, and IL.
Description
After a test in which a low SpO2 (yellow) medium grade alarm initiated in neo-natal mode and was subsequently paused, the high grade life threatening SpO2 alarm (red) did not activate when the SpO2 values were decreased to reach the red alarm limit.
Product
Draeger Infinity Acute Care System Monitoring Solution
Manufacturer(s)
Draeger Medical Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →