Z-1746-2014Class II

IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX)...

Name: Z-1746-2014 IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX)...
Creator: Philips Medical Systems, Inc.
Published: 2014-05-22
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2014-05-22 / Terminated / root cause: software

FDA source

Philips Medical Systems, Inc. began a recall of IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX); 865350, 865351, 865352 on 2014-05-22. FDA classified it as Class II and gives the reason as "IntelliVue MX40 (part numbers 865350, 865352) with software revisions B.00 or B.01 may not resume alarming when the alarms are paused and the pause timer ends". 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-1746-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-22
Posted: 2014-06-10
Terminated: 2018-05-16
Recalling firm: Philips North America LLC
Product: IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX); 865350, 865351, 865352
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: IntelliVue MX40 (part numbers 865350, 865352) with software revisions B.00 or B.01 may not resume alarming when the alarms are paused and the pause timer ends.
Root cause tag: software
FDA root cause: Software design
Action: On May 22, 2014, each affected customer was sent an Urgent Medical Device Correction notification/Field Safety Notice. The letter explains the problem, explains the action to be taken by the consumer, and the action planned by Philips. The Urgent Medical Device Correction notification/Field Safety Notice informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. The correction will consist of a free of charge software upgrade. A Philips Healthcare representative will contact customers with affected devices to arrange for service. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Urgent Medical Device Correction notification/Field Safety Notice: The following two items must be configured when using MX40 with the IntelliVue Information Center iX: 1. Utilize the default state of Pause Alarms at Yellow only, which disables the ability to Pause/Suspend all Red level alarms Utilize the default state of Remote Suspend Alarms as Off, which disables the use of the Pause Alarms feature at the MX40 device
Quantity in commerce: 42,600
Distribution: United States: Nationwide Foreign Countries: Germany, Austria, Finland, Sweden, Australia, Qatar, Canada, Netherlands, New Zealand, Portugal, United Kingdom, Spain, Belgium, France, Switzerland, Norway, Czech Republic, Poland, Italy, Singapore, Denmark, Iceland, India, Saudi Arabia, Ireland, Oman, Bahrain, Japan, Israel, Malaysia, South Africa, Turkey, Thailand, Latvia, Bulgaria, Indonesia, Slovenia, United Arab Emirates, Hong Kong, Aruba, Chile, Lebanon, Korea, Kuwait, Taiwan, Argentina, Hungary, Luxembourg, Mexico, Gabon
Product codes and lots: Serial numbers within the following ranges that have the MX40 interfaces: 00700001 - US01443745 and US014Z1301 - US014Z1431

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1746-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1746-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-10

Product code MHX

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)