Z-0714-2014Class II

Draeger Infinity Acute Care System Monitoring Solution

Name: Z-0714-2014 Draeger Infinity Acute Care System Monitoring Solution
Creator: Draeger Medical Systems, Inc.
Published: 2013-12-10
License: https://open.fda.gov/license/

Draeger Medical Systems, Inc. / initiated 2013-12-10 / Terminated / root cause: software

FDA source

Draeger Medical Systems, Inc. began a recall of Draeger Infinity Acute Care System Monitoring Solution on 2013-12-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0714-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-10
Posted: 2014-01-10
Terminated: 2015-05-20
Recalling firm: Draeger Medical Systems, Inc.
Product: Draeger Infinity Acute Care System Monitoring Solution
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
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.
Root cause tag: software
FDA 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 in commerce: 439
Distribution: US Distribution including the states of: MA, NH, IN, CA, TX, NY, OK, and IL.
Product codes and lots: with software versions VG2.0.3 and higher.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0714-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0714-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-10

Product code MHX

K113798Class IIInfinity Acute Care System, Infinity Mcable- Masimo Rainbow SetDraeger Medical Systems, Inc. / cleared 2012-03-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)