Z-0291-2017Class II

Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 WMTS Smart-hopping (1.4GHz) Product Number: 865350...

Name: Z-0291-2017 Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 WMTS Smart-hopping (1.4GHz) Product Number: 865350...
Creator: Philips Electronics North America Corporation
Published: 2016-09-19
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2016-09-19 / Terminated / root cause: software

FDA source

Philips Electronics North America Corporation began a recall of Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 WMTS Smart-hopping (1.4GHz) Product Number: 865350 Exchange part: 453564262491 453564262511... on 2016-09-19. FDA classified it as Class II and gives the reason as "Philips IntelliVue MX40 Patient Wearable Monitor Configuration Setting Disables Generation and Delivery of ECG Alarms to PIIC iX". 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-0291-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-19
Posted: 2016-10-20
Terminated: 2018-05-25
Recalling firm: Philips North America LLC
Product: Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 WMTS Smart-hopping (1.4GHz) Product Number: 865350 Exchange part: 453564262491 453564262511 453564615311 453564615331 453564262571 453564262591 USA only SW Revisions: B.05.28, B.05.29, and B.05.32 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: Philips IntelliVue MX40 Patient Wearable Monitor Configuration Setting Disables Generation and Delivery of ECG Alarms to PIIC iX
Root cause tag: software
FDA root cause: Software design
Action: The firm, Philips Healthcare, sent a "Field Safety Notice (FSN)" dated 9/14/2016 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to make sure that the MX40 Patient Wearable Monitor local configuration setting 'Alarms On' is configured to its factory default until your software is upgraded; and follow the instructions listed in the letter. A Philips Healthcare representative will contact customers with affected devices to arrange for the installation of the software upgrade. If you need any further information or support concerning this issue, please contact Philips Customer Support at 1-800-722-9377.
Quantity in commerce: 9804 units
Distribution: Worldwide Distribution-US (Nationwide) and countries of: Aruba, Australia, Austria, Belgium, Bulgaria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Ghana, Greece, Hong Kong, Iceland, India, Iraq, Ireland, Italy, Japan, Korea, Republic of, Malaysia, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Singapore, Slovenia, South Africa, Spain Sweden, Switzerland, Thailand, Turkey, United Arab Emirates and United Kingdom.
Product codes and lots: SW Revisions: B.05.28, B.05.29, and B.05.32

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0291-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0291-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0292-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0293-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20

Product code MHX

K113125Class IIIntellivue Mx40 Patient MonitorPhilips Medical Systems / cleared 2011-11-17

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)