Draeger Infinity Acute Care System Monitoring Solution — Class II medical device recall Z-0714-2014
Terminated recall by Draeger Medical Systems, Inc., reported 2014-01-22, distributed in CA, IL, IN, MA, NH, NY, OK, TX. After a test in which a low SpO2 (yellow) medium grade alarm initiated in neo-natal mode and was subsequently
| Recall number | Z-0714-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Draeger Medical Systems, Inc., Telford, PA, United States |
| Recall initiated | 2013-12-10 |
| Classified | 2014-01-10 |
| Reported by FDA | 2014-01-22 |
| Terminated | 2015-05-20 |
| Distributed | CA, IL, IN, MA, NH, NY, OK, TX |
| Quantity | 439 |
Product
Draeger Infinity Acute Care System Monitoring Solution
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.