FDA Device recall Z-0714-2014
Draeger Infinity Acute Care System Monitoring Solution
- FDA Device
- Class II
- terminated
- Published 2014-01-22
On 2014-01-22 the FDA classified a Class II recall of Draeger Infinity Acute Care System Monitoring Solution by Draeger Medical Systems, citing 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 acti….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0714-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-12-10 |
| Published | 2014-01-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Draeger Medical Systems |
| Distribution | CA, IL, IN, MA, NH, NY, OK, TX |
Product
Draeger Infinity Acute Care System Monitoring Solution
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.
Identifiers
| code_info | with software versions VG2.0.3 and higher. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0714-2014%22
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