Philips North America, LLC: IntelliVue MX40 Patient Monitor, Product number 865351, Service Numbers All other countries: 453564451791, 453564451811, 453564467721, 453564467741, 453564467761, 453564467781, 453564467801, 453564467821, 453564467841, 453564467861, 453564262531, and 453564262551 - 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.

Recall number

Z-1693-2019

Recalling firm

Philips North America, LLC

Product

IntelliVue MX40 Patient Monitor, Product number 865351, Service Numbers All other countries: 453564451791, 453564451811, 453564467721, 453564467741, 453564467761, 453564467781, 453564467801, 453564467821, 453564467841, 453564467861, 453564262531, and 453564262551 - 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.

Status

Open, Classified

Initiated

2019-03-28

Posted

not on file

Terminated

not on file

Reason

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

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.

Quantity

not on file

Distribution

Worldwide distribution - US Nationwide and to 71 countries.

Lot, serial or model codes

All revision B.X versions are affected.

510(k) numbers

["K113125"]

PMA numbers

not on file

Product code

DSI

Firm FEI

1218950

Firm city

Andover

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy