# K153702: M3290B Philips IntelliVue Information Center iX

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems
- Decided: Jun 13, 2016 after 173 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 24 generations back to K941811 (1994). 136 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 140 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143057: M3290B Philips IntelliVue Information Center iX, Philips Medical Systems (2014) Summary page 4.

## Most influential descendants
- K163584: M3290B Philips IntelliVue Information Center iX (2017), 2 descendants of its own
- K183387: M3290B Patient Information Center iX (2019), 0 descendants of its own
- K173203: Athena GTX Device Management Suite (ADMS) Software (2018), 0 descendants of its own

## Recalls of this device
- Jul 31, 2026 · Class II · Z-3142-2026: Due to software malfunction, patient information system may freeze and become unresponsive.
- Jul 31, 2026 · Class II · Z-3141-2026: Due to software malfunction, patient information system may freeze and become unresponsive.
- Dec 22, 2025 · Class II · Z-1156-2026: A recent software (SW) patch modifies Mobile Event Notification filter settings without providing any indication to the user when upgrading the system.
- Apr 19, 2024 · Class II · Z-1827-2024: Event Catalog information does not save when copied and transferred from one unit to another.
- Mar 22, 2024 · Class II · Z-1690-2024: Possible failure of Uninterruptable Power Supply (UPS) devices supporting the Patient Information Center (PIC) iX system, potential for the associated PIC iX system to shut down due to the lack of pow
- Feb 28, 2024 · Class II · Z-1386-2024: It was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play custom ringtones when iOS device screens were locked with a passcode.
- Feb 15, 2024 · Class II · Z-3312-2024: If the DIVA touch display generates touch inputs without user interaction, due to possibility of the erroneous acknowledgement of a patient alarm, there is a potential for a delay in the detection of 
- Nov 28, 2023 · Class II · Z-0731-2024: Push notifications may fail to send to the user under certain conditions. This could potentially result in patient harm due to delay in detection of a change in patient condition.
- Nov 28, 2023 · Class II · Z-0732-2024: Push notifications may fail to send to the user under certain conditions. This could potentially result in patient harm due to delay in detection of a change in patient condition.
- Aug 17, 2023 · Class II · Z-2608-2023: Patient Information Center (PIC iX) Release 4.x Surveillance Crash Caused by Intel Graphics Driver Error-with a blank screen and subsequently require a manual reboot of the hardware to restart and con
- 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
- Apr 29, 2019 · Class III · Z-1771-2019: Infusion Pump Data Storage Accuracy-Data from the BBraun Space LAN or Arcomed UniqueDoc infusion pumps transmitted via the HL7 output interface through the Patient Information Center iX using a LAN dr

## Indications for use
The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, format data for strip chart recordings and printed reports, and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. An additional intended use of the Information Center Software is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors. This product is intended for use in health care facilities by trained healthcare professionals. This product is not intended for home use. Indicated for central monitoring of multiple adult and all pediatric subgroups (Newborn (neonate), Infant, Child, Adolescent) patients; and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

Source page: https://510kreport.com/device/K153702
Methodology: https://510kreport.com/methodology