FDA-Device2014-01-22Class II
Draeger Infinity Acute Care System Monitoring Solution
Draeger Medical Systems, Inc.
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.
Sold states
US Distribution including the states of: MA, NH, IN, CA, TX, NY, OK, and IL.
Affected count
439
Manufactured in
3135 Quarry Rd, Telford, PA, United States
Products
Draeger Infinity Acute Care System Monitoring Solution
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0714-2014Don't want to check this manually?
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