Draeger Infinity Acute Care System Monitoring Solution
- Company
- Draeger Medical Systems, Inc.
- Recall Initiated
- December 10, 2013
- Posted
- January 10, 2014
- Terminated
- May 20, 2015
- Recall Number
- Z-0714-2014
- Quantity
- 439
- Firm Location
- Telford, PA
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.
Distribution
US Distribution including the states of: MA, NH, IN, CA, TX, NY, OK, and IL.
Lot / Code Info
with software versions VG2.0.3 and higher.
Root Cause
Software design
Action Taken
An Urgent Medical Device Recall Letter, dated December 2013, was sent to Users. Once available Drager will update components of the IACS Monitoring Solution System.
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