FDAFDA · Food and drugs·Recall number Z-0714-2014
Draeger Infinity Acute Care System Monitoring Solution
Published January 22, 2014 · Recall initiated: December 10, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Draeger Medical Systems, Inc.
- Distributor
- US Distribution including the states of: MA, NH, IN, CA, TX, NY, OK, and IL.
- Lot
- with software versions VG2.0.3 and higher.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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