# K041741: M3290A Intellivue Information Center Software Release F.0 and M4840A Philips Telemetry System II Including M4841A Patien

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems, Inc.
- Decided: Jul 21, 2004 after 23 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K941811 (1994). 64 ancestors in all.
155 later devices descend from it; 7 cite it directly.
0 of 220 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040357: M3290A Intellivue Information Center Software Release F.O and the M4840A Telemetry Monitoring System II, Philips Medical Systems, Inc. (2004) Summary page 1.

## Most influential descendants
- K081793: Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue Telemetry System Transceiver (2008), 143 descendants of its own
- K100939: Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP75, MP80 and MP90 (2010), 123 descendants of its own
- K102562: Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, & MX800 (2010), 103 descendants of its own
- K101449: Intellivue Patient Monitor (2010), 92 descendants of its own
- K110622: Intellivue Patient Monitor (2011), 90 descendants of its own

## Recalls of this device
- Mar 5, 2020 · Class II · Z-1767-2020: The ECG signal from patients being monitored using a Philips TRx4841A and TRx4851A Telemetry Transceiver may not be properly analyzed when it is used with a Philips Patient Information Center iX Relea
- Mar 5, 2020 · Class II · Z-1766-2020: The ECG signal from patients being monitored using a Philips TRx4841A and TRx4851A Telemetry Transceiver may not be properly analyzed when it is used with a Philips Patient Information Center iX Relea
- Aug 23, 2019 · Class II · Z-2547-2019: Remote Antenna Cable Used with Philips MX4O Monitors Does Not Have the Required Rating for Some Installations
- Jul 8, 2013 · Class II · Z-1780-2013: IntelliVue Smart-hopping 1.4 GHz Access Point may experience unexpected signal loss of several minutes impacting wireless connectivity

## Indications for use
M3290A: For central monitoring of multiple adult, pediatric, and neonatal 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. M4840A: For ambulatory and bedside monitoring of ECG and SP 0 2 parameters of adult and pediatric patients in healthcare facilities to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

Source page: https://510kreport.com/device/K041741
Methodology: https://510kreport.com/methodology