Reported Jan 22, 2014 · Terminated
Draeger Infinity Acute Care System Monitoring Solution
Draeger Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Draeger Medical Systems, Inc. · 3135 Quarry Rd · Telford, PA · 18969-1042
Is this the product you have?
- Draeger Infinity Acute Care System Monitoring Solution
- Lot codes and dates
- with software versions VG2.0.3 and higher.
- Amount recalled
- 439
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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