Company: Draeger Medical Systems, Inc. .
Date of Enforcement Report:1/22/2014
Class lI:
PRODUCT
Draeger Infinity Acute Care System Monitoring Solution Recall Number Z-0714-2014
REASON
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.
RECALLING FIRM/MANUFACTURER
Draeger Medical Systems, Inc. on 12/10/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
439
DISTRIBUTION
Nationwide
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