IntelliVue Multi-Measurement Module X3 IntelliVue X3Recalls & reported problems
Philips Medizin Systeme Böblingen GmbH · IntelliVue Multi-Measurement Module X3, compact, battery operated patient monitor and multi-measurement module. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Philips IntelliVue X3 module is a battery-powered patient monitor. Of its 1,135 reports, 19 describe a patient death, 49 describe injuries and 1,067 describe malfunctions. Many reports describe the monitor not sounding its alarm or prompt tones, along with incorrect measurements. Reports rose to 325 in the last 12 months from 193 in the previous 12 months. 1 open recall, started in October 2025, concerns monitors that did not alarm.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 1,172
- Deaths reported
- 19
- Injuries reported
- 47
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1,172 adverse event reports that list this exact device (DI 00884838082588), received between Mar 27, 2018 and Sep 30, 2026 — classified as 19 deaths, 47 injuries, 1,106 malfunctions.
The most frequently reported specific device problem is “No Audible Alarm” (385 reports).
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Oct 31, 2025Class IIOpen, Classified
Potential issue where the IntelliVue monitors did not alarm.
Z-0860-2026 · Root cause: Use error · Recall details · FDA record ↗
Most reported problems
Device problems
- No Audible Alarm385
- No Audible Prompt/Feedback357
- Incorrect Measurement109
- Defective Alarm90
- Low Readings37
- Unable to Obtain Readings30
- Imprecise or Erratic Results19
- Therapeutic or Diagnostic Output Failure19
Patient problems
- No Clinical Signs, Symptoms or Conditions1,058
- Insufficient Information41
- No Known Impact Or Consequence To Patient39
- No Patient Involvement8
- Cardiac Arrest7
- High Blood Pressure/ Hypertension7
- Low Oxygen Saturation5
- Bruise/Contusion4
Recent adverse event reports
The 25 most recent of 1,172 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026No Audible Prompt/Feedback
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952122 ↗MalfunctionSep 30, 2026No Audible Alarm
It was reported that a speaker malfunction occurred. When the device is turned on there are no tones heard. The device was not in use on a patient at the time of the event. There was no adverse event reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945700 ↗MalfunctionSep 30, 2026No Audible Alarm
It was reported that the device was presented with a speaker malfunction error message and there was no sound coming from the device in standalone mode. The device was in clinical use. There was no report of patient or user harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943847 ↗MalfunctionSep 29, 2026Failure to Deflate
It was reported the device is having issues with taking blood pressure as it keeps pumping. The device was not in clinical use. There was no report of patient or user harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931736 ↗MalfunctionSep 28, 2026No Audible Alarm
It was reported that the patient had a drop in blood pressure with a cardiac arrest, and the device did not alarm. The device was in clinical use at time of event, no patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916731 ↗MalfunctionSep 28, 2026Incorrect Measurement
The customer reported an issue with getting the pulse ox wave and the blue numbers but will show zero. It is unknown if the device was in use on a patient at the time of the event. There was no adverse event reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915655 ↗MalfunctionSep 25, 2026Unable to Obtain Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50904084 ↗MalfunctionSep 25, 2026Imprecise or Erratic Results
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902851 ↗MalfunctionSep 25, 2026No Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902405 ↗MalfunctionSep 25, 2026Incorrect Measurement
Philips received a complaint on an IntelliVue X3 Patient monitor indicating that the NBP will not give bottom number, it goes straight to zero. It is unknown if the device was in clinical use at time of event, no adverse event was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50900131 ↗MalfunctionSep 25, 2026Inflation Problem
Customer reported that Second blood pressure cuff inflates but does not deflate posing safety risk for long case. The device was in clinical use at time of event, no adverse event was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896387 ↗MalfunctionSep 25, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892537 ↗MalfunctionSep 23, 2026Failure to Deflate
Philips received a complaint on an IntelliVue X3 Patient monitor indicating the blood pressure cuff inflates, but does not measure or does not release the air. It is unknown if the device was in clinical use at the time the issue was discovered. There was no adverse event or patient harm reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50866973 ↗MalfunctionSep 22, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50857594 ↗MalfunctionSep 22, 2026Incorrect Measurement
It was reported that the saturation measurement is faulty. It is asked but unknown if the device was in clinical use. There was no report of patient or user harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50856465 ↗MalfunctionSep 22, 2026Incorrect Measurement
Philips received a complaint on an IntelliVue X3 Patient monitor indicating that the ECG waveform was displayed clearly, but the heartrate (HR) count was doubled. Replacing the electrode patch did not resolve the issue. When other devices were used on the same patient, the HR was correct. The device was in use on a patient at time of event, there was no adverse event reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50853997 ↗MalfunctionSep 21, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846965 ↗MalfunctionSep 21, 2026No Audible Alarm
It was reported that a speaker malfunction occurred and the speaker emits no sound. The device was in use on a patient at the time of the event. There was no adverse event reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50838015 ↗MalfunctionSep 18, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50827742 ↗MalfunctionSep 18, 2026High Readings
It was reported that the diastolic blood pressure reading is high. The device was not in clinical use. There was no report of patient or user harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50814398 ↗MalfunctionSep 16, 2026No Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50793357 ↗MalfunctionSep 15, 2026Defective Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50781419 ↗MalfunctionSep 15, 2026No Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780265 ↗MalfunctionSep 15, 2026High Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50773871 ↗MalfunctionSep 15, 2026No Audible Alarm
It was reported the device is presented with a speaker malfunction INOP error. It is unknown if there was still sound coming from the device in standalone mode. The device was in clinical use. There was no report of patient or user harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50767613 ↗
Other MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) devices
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- NA PU-681RANihon Kohden Corporation · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)22 deaths1,493 reports
- Patient Information Center IXPhilips Medical Systems Hsg · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)82 deaths941 reports
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- Tempus Pro 00-1024-RRemote Diagnostic Technologies Limited · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)5 recalls541 reports
- Tempus Pro 00-1026-RRemote Diagnostic Technologies Limited · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)7 recalls1 death324 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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