Recall Z-0714-2014 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Draeger Medical Systems, Inc.
Draeger Infinity Acute Care System Monitoring Solution
| Date | Jan 10, 2014 (initiated Dec 10, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 439 |
| Distribution | US Distribution including the states of: MA, NH, IN, CA, TX, NY, OK, and IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113798 | INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SET Draeger Medical Systems, Inc., Mar 22, 2012 |