Draeger Infinity Acute Care System Monitoring Solution
Reported: January 22, 2014 Initiated: December 10, 2013 #Z-0714-2014
Product Description
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.
Details
- Recalling Firm
- Draeger Medical Systems, Inc.
- Units Affected
- 439
- Distribution
- US Distribution including the states of: MA, NH, IN, CA, TX, NY, OK, and IL.
- Location
- Telford, PA
Frequently Asked Questions
What product was recalled? ▼
Draeger Infinity Acute Care System Monitoring Solution. Recalled by Draeger Medical Systems, Inc.. Units affected: 439.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 22, 2014. Severity: Moderate. Recall number: Z-0714-2014.
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