Draeger Infinity Acute Care System Monitoring Solution
FDA Recall Z-0714-2014 · Posted 2014-01-10
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Recalling FirmDraeger Medical Systems, Inc.
Recall StatusTerminated
Product CodeMHX
Date Initiated2013-12-10
Date Terminated2015-05-20
Product Quantity439
Reason for Recall
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.
Firm Action
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.
Root Cause
Software design
Distribution Pattern
US Distribution including the states of: MA, NH, IN, CA, TX, NY, OK, and IL.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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