Z-1692-2019Class II

IntelliVue MX40 Patient Monitor, Product number 865350, Service # USA: 453564262491 and 453564262511 -

Name: Z-1692-2019 IntelliVue MX40 Patient Monitor, Product number 865350, Service # USA: 453564262491 and 453564262511 -
Creator: Philips North America, LLC
Published: 2019-03-28
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2019-03-28 / Open, Classified / root cause: software

FDA source

Philips North America, LLC began a recall of IntelliVue MX40 Patient Monitor, Product number 865350, Service # USA: 453564262491 and 453564262511 - Product Usage: Used primarily as a traditional telemetry... on 2019-03-28. FDA classified it as Class II and gives the reason as "The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1692-2019
Classification: Class II
Status: Open, Classified
Initiated: 2019-03-28
Posted: 2019-06-01
Recalling firm: Philips North America LLC
Product: IntelliVue MX40 Patient Monitor, Product number 865350, Service # USA: 453564262491 and 453564262511 - Product Usage: Used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX40 is connected to the IntelliVue Information Center the IntelliVue Information Center provides the primary patient monitoring and alarming function. The MX40 does not automatically provide local monitoring or alarming when connected to the Information Center.
Product code: DSI Detector And Alarm, Arrhythmia
Reason for recall: The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State .
Root cause tag: software
FDA root cause: Software design
Action: On March 28, 2019, Philips Healthcare distributed URGENT MEDICAL DEVICE RECALL notices (FSN 86201863A) dated March 22, 2019 to customers via courier service. Actions To Be Taken by Customer/User at the time was as follows: - MX4O monitors can continue to be used while awaiting a software upgrade. - Customers should maintain an adequate supply of fully charged batteries given the approximately 25% increased power consumption. Switch to continuous or manual SO2 measurements if your unit is using automatic measurement mode. On April 24, 2019, Philips Healthcare distributed UPDATE URGENT MEDICAL DEVICE RECALL notices (FSN86201863B) dated April 16, 2019 to customers via courier service. Actions To Be Taken by Customer/User is currently as follows: Until you have upgraded the software on your MX4Os, replace your batteries every 8 hours, unless you are using continuous monitoring mode and Sp02 monitoring with AA batteries, in which case replacement should be done every 2 hours. Philips Healthcare will release a software upgrade, which will correct this problem. Philips will contact you to arrange for software correction. If you need any further information or support concerning this issue please contact your local Philips representative or Philips Customer Support at 1-800- SUPPORT 722-9377.
Distribution: Worldwide distribution - US Nationwide and to 71 countries.
Product codes and lots: All revision B.X versions are affected.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1692-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1692-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-06-12	2019-05-31
Z-1693-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-06-12	2019-05-31
Z-1694-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-06-12	2019-05-31
Z-1695-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-06-12	2019-05-31

Product code DSI

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)