Class II — Draeger Medical Systems, Inc.
| Recalling firm | Draeger Medical Systems, Inc. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| Product | Draeger Infinity Acute Care System Monitoring Solution |
| Quantity | 439 |
| Distribution | US Distribution including the states of: MA, NH, IN, CA, TX, NY, OK, and IL. |
| Initiated | 2013-12-10 |
| Classified | 2014-01-10 |
| Terminated | 2015-05-20 |
| Recall number | Z-0714-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Draeger Medical Systems, Inc. (Z-0714-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67056/
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