Draeger Infinity Acute Care System Monitoring Solution recallZ-0714-2014 · Draeger Medical Systems, Inc. · initiated Dec 10, 2013
Class II Terminated All recalls posted in January 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Draeger Medical Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-0714-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Dec 10, 2013
- Posted by the FDA
- Jan 10, 2014
- Recalling firm
- Draeger Medical Systems, Inc.
- Quantity
- 439
- Product code
- MHX
- FDA submissions
- K113798
- Distribution
- US Distribution including the states of: MA, NH, IN, CA, TX, NY, OK, and IL.
Product description
Draeger Infinity Acute Care System Monitoring Solution
Code information (models, lots, serial numbers)
with software versions VG2.0.3 and higher.
Other devices under the same FDA submission
5 devices cleared under K113798 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- SHP UNT INFINITY M540 MS20401Draeger Medical Systems, Inc. · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)2 recalls5 deaths62 reports
- IACS w/C700 MS25520Draeger Medical Systems, Inc. · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)2 recalls1 death27 reports
- IACS w/C500 MS25510Draeger Medical Systems, Inc. · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)2 recalls2 deaths25 reports
- Infinity M540 MS26372Draeger Medical Systems, Inc. · System,Network And Communication,Physiological Monitors2 recalls9 reports
- Infinity Mpod Quad Hemo MS20725Draeger Medical Systems, Inc. · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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