# K113125: Intellivue MX40 Patient Monitor

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems
- Decided: Nov 17, 2011 after 24 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 16 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 27 generations back to K941811 (1994). 168 ancestors in all.
14 later devices descend from it; 1 cites it directly.
0 of 183 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103646: Intellivue MX40 Patient Monitor, Phillips Medical Systems (2011) Summary page 1.

## Most influential descendants
- K172226: MX40 Release B.07 (2017), 13 descendants of its own
- K193391: BeneVision Central Monitoring System (2020), 10 descendants of its own
- K220058: BeneVision Central Monitoring System (2022), 3 descendants of its own
- K223567: CNS-2101 Central Monitor (2023), 2 descendants of its own
- K242750: Central Station (2025), 1 descendant of its own

## Recalls of this device
- Apr 19, 2023 · Class II · Z-0035-2025: During extended operation of the MX40 with the PIC iX, the DHCP (Dynamic Host Configuration Protocol) lease can expire on the MX40. If the DHCP lease expires while the device is offline, upon reconnec
- Feb 2, 2021 · Class II · Z-1671-2021: Manufacturing failed to follow process steps resulting in the distribution of potentially defective devices
- Mar 28, 2019 · Class II · Z-1694-2019: The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State .
- Mar 28, 2019 · Class II · Z-1692-2019: The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State .
- Mar 28, 2019 · Class II · Z-1693-2019: The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State .
- Mar 28, 2019 · Class II · Z-1695-2019: The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State .
- Oct 10, 2018 · Class II · Z-0592-2019: A problem has been detected in the Philips IntelliVue MX4O that, if it were to occur, could affect the performance of the equipment. The volume of the MX4O speaker in these devices may be diminished o
- Apr 30, 2018 · Class II · Z-2142-2018: Five warning statements are missing from the instructions for use.
- Apr 30, 2018 · Class II · Z-2143-2018: Five warning statements are missing from the instructions for use.
- Apr 30, 2018 · Class II · Z-2144-2018: Five warning statements are missing from the instructions for use.
- Apr 30, 2018 · Class II · Z-2141-2018: Five warning statements are missing from the instructions for use.
- Mar 6, 2017 · Class II · Z-1707-2017: Philips lntelliVue MX4O WLAN Patient Wearable Monitor may not automatically switch to Monitor Mode with audible alarms when association with central monitoring system is unsuccessful [incomplete]
- Sep 19, 2016 · Class II · Z-0293-2017: Philips IntelliVue MX40 Patient Wearable Monitor Configuration Setting Disables Generation and Delivery of ECG Alarms to PIIC iX
- Sep 19, 2016 · Class II · Z-0291-2017: Philips IntelliVue MX40 Patient Wearable Monitor Configuration Setting Disables Generation and Delivery of ECG Alarms to PIIC iX
- Sep 19, 2016 · Class II · Z-0292-2017: Philips IntelliVue MX40 Patient Wearable Monitor Configuration Setting Disables Generation and Delivery of ECG Alarms to PIIC iX
- May 22, 2014 · Class II · Z-1746-2014: 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K113125
Methodology: https://510kreport.com/methodology