FDA Device

Draeger Infinity Acute Care System Monitoring Solution

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.

What You Should Do

Remedy

An Urgent Medical Device Recall Letter, dated December 2013, was sent to Users. Once available Drager will update components of the IACS Monitoring Solution System.

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Products

Draeger Infinity Acute Care System Monitoring Solution
Brand
Draeger Medical Systems, Inc.
UPC
with software versions VG2.0.3 and higher.

Units Affected

439

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