IntelliVue MX500 Patient Monitor IntelliVue Patient Monitor MX500Recalls & reported problems
Philips Medizin Systeme Böblingen GmbH · The IntelliVue MX500 patient monitor is operated primarily via touch screen. It has an integrated 12" TFT widescreen touch display and is compatible with the IntelliVue Multi Measurement Module (M3001A)/ IntelliVue X2 (M3002A) and all Multi-Measurement Module Extensions/IntelliVue MMX (867036)/ IntelliVue X3 (867030). The monitor has 3 module slots built-in, that are compatible with supported IntelliVue single and dual width measurement modules (see Technical Data Sheet for list of supported modules).The IntelliVue MX500 comes with a built-in battery bay as standard (battery not included in base product), built-in comfort handle and integrated power supply in order to make the monitor easily portable. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
5 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Philips IntelliVue MX500 patient monitor tracks vital signs and sounds alarms. Of its 128 reports, 113 are malfunctions, 9 are injuries and 6 describe deaths; many describe the monitor not sounding its alarm or freezing. Reports rose to 28 in the last 12 months from 18 in the 12 months before. 5 recalls are open, covering missed alarms, software options, a grounding bolt and factory settings.
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
- 133
- Deaths reported
- 6
- Injuries reported
- 9
- Recalls naming it
- 5
Summary
The FDA's MAUDE database contains 133 adverse event reports that list this exact device (DI 00884838038776), received between Feb 2, 2018 and Sep 28, 2026 — classified as 6 deaths, 9 injuries, 118 malfunctions.
The most frequently reported specific device problem is “No Audible Alarm” (60 reports).
5 FDA recall records name this device's identifier, 5 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-0864-2026 · Root cause: Use error · Recall details · FDA record ↗
- Jan 15, 2025Class IIOpen, Classified
Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
Z-1109-2025 · Root cause: Software design · Recall details · FDA record ↗
- Aug 30, 2024Class IIOpen, Classified
During a production process, Philips became aware of one IntelliVue power supply with a broken ground bolt upon disconnection of the ground cable from the equipotential ground connector. Loss of electrical grounding may negatively affect the devices electromagnetic immunity and emission.
Z-3249-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Jun 28, 2024Class IIOpen, Classified
Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software Options. Changes were made to reflect some options becoming standard capabilities for software-version N.x. In the process, the entitlements of software options MOS, M06, and M20 were removed for software versions L.x and M.x. As a result of these changes Patient Monitors manufactured with or updated to the latest versions of software L.x or M.x will not offer the capabilities> Mmonitors with software version K.x may experience this issue too, due to software version K being out of support and the devices being provided with L.x entitlements offered by software options MOS, M06, and M20. Potential for incorrect or delayed treatment for the patient,
Z-2510-2024 · Root cause: Software design · Recall details · FDA record ↗
- Jun 14, 2023Class IIOpen, Classified
Devices with Option CP2 and initially programmed to software version P.01.01 were configured incorrectly at the factory. Therefore, Enhanced ECG Capabilities provided by Option CP2 were not enabled in these devices. Without Option C01 Full Arrhythmia, the device will not provide the yellow alarms for enhanced arrhythmia detection. This is a retrospectively reported recall from 6/14/23.
Z-0020-2025 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- No Audible Alarm60
- No Audible Prompt/Feedback19
- Defective Alarm16
- Incorrect Measurement9
- Device Alarm System7
- Application Program Freezes or Fails to Launch6
- Adverse Event Without Identified Device or Use Problem3
- Device Displays Incorrect Message3
Patient problems
- No Clinical Signs, Symptoms or Conditions102
- No Known Impact Or Consequence To Patient9
- Insufficient Information8
- No Patient Involvement5
- Bradycardia2
- Death2
- Low Blood Pressure/ Hypotension2
- Low Oxygen Saturation2
Recent adverse event reports
The 25 most recent of 133 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026No Audible Alarm
It was reported that during a preventive maintenance the device did not produce any audible APNEA alarm. 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 50916307 ↗MalfunctionSep 25, 2026No Audible Prompt/Feedback
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50901456 ↗MalfunctionSep 25, 2026Defective Alarm
Philips received a complaint on the IntelliVue MX500 Patient Monitor indicating that the monitor intermittently generates false Ventricular Tachycardia red alarms when the patient had a high heartrate with Atrial Fibrillation rhythms. 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 50899388 ↗MalfunctionSep 21, 2026Low Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846480 ↗MalfunctionSep 19, 2026No Audible Prompt/Feedback
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50832716 ↗MalfunctionSep 18, 2026No Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50817398 ↗MalfunctionSep 8, 2026No Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50674001 ↗MalfunctionAug 20, 2026No Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50349045 ↗MalfunctionAug 20, 2026Application Program Freezes or Fails to Launch
It was reported that the monitor was completely frozen. It was unknown whether the parameters and waveforms were also frozen. 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 50346414 ↗MalfunctionAug 17, 2026Incorrect Measurement
It was reported that the device was providing inaccurate ECG data. 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 50272471 ↗MalfunctionAug 12, 2026No Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50222728 ↗MalfunctionAug 11, 2026No Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50211841 ↗MalfunctionAug 3, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50116315 ↗MalfunctionJul 1, 2026No Audible Alarm
IT WAS REPORTED THE DEVICE HAS A SPEAKER MALFUNCTION. 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 25675800 ↗MalfunctionJun 30, 2026Incorrect Measurement
PHILIPS RECEIVED A COMPLAINT ON AN INTELLIVUE MX500 PATIENT MONITOR INDICATING THAT DURING TESTING OF THE DEVICE, IT WAS IDENTIFIED THAT THE NON-INVASIVE BLOOD PRESSURE (NIBP) MEASUREMENT WAS INCORRECT. THE DEVICE WAS NOT IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25668270 ↗MalfunctionJun 11, 2026Incorrect Measurement
PHILIPS RECEIVED A COMPLAINT ON THE INTELLIVUE MX500 PATIENT MONITOR INDICATING THAT THE PULSE OXIMETRY WAS NOT READING CORRECTLY. IT IS UNKNOWN IF THE DEVICE WAS IN CLINICAL USE ON A PATIENT AT THE TIME OF THE EVENT. NO ADVERSE EVENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25472090 ↗MalfunctionJun 10, 2026No Audible Alarm
IT WAS REPORTED THE DEVICE WAS PRESENTED WITH A SPEAKER MALFUNCTION ERROR MESSAGE. NO SOUND WAS COMING FROM THE DEVICE. 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 25459879 ↗MalfunctionMay 11, 2026Defective Alarm
PHILIPS RECEIVED A COMPLAINT ON THE INTELLIVUE MX500 PATIENT MONITOR INDICATING THAT DURING A USER CHECK THEY WERE UNABLE TO VIEW ALARMS FOR OTHER HOSPITAL BEDS. THE DEVICE WAS NOT IN USE AT THE TIME OF THE EVENT. NO ADVERSE EVENT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25136748 ↗MalfunctionMay 4, 2026No Audible Alarm; No Audible Prompt/Feedback
PHILIPS RECEIVED A COMPLAINT ON AN INTELLIVUE MX500 PATIENT MONITOR INDICATING THAT THE SPEAKER WAS ABNORMAL. THE DEVICE WAS NOT IN USE ON PATIENT AT TIME OF EVENT; THERE WAS NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25070505 ↗MalfunctionApr 24, 2026No Audible Alarm
IT WAS REPORTED THAT A SPEAKER MALFUNCTION OCCURRED AND THE SPEAKER EMITS NO SOUND. 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 24980799 ↗MalfunctionMar 31, 2026No Audible Alarm
PHILIPS RECEIVED A COMPLAINT ON AN INTELLIVUE MX500 PATIENT MONITOR INDICATING THAT A SPEAKER MALFUNCTION ERROR WAS DISPLAYED AND THERE WAS NO AUDIBLE SOUND. THE DEVICE WAS NOT IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24746798 ↗MalfunctionMar 26, 2026No Audible Alarm
IT WAS REPORTED THE DEVICE WAS PRESENTED WITH A SPEAKER MALFUNCTION ERROR MESSAGE AND NO SOUND WAS COMING FROM THE DEVICE. 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 24698955 ↗DeathMar 11, 2026Device Alarm System
IT WAS REPORTED THE PRESSURE ALARMS WERE CONFIGURED AS YELLOW ALARMS AND NOT RED, WHICH RESULTED IN THE PATIENT DEATH. THE STAFF DOES NOT RESPOND TO YELLOW ALARMS DUE TO THE VOLUME OF ALARMS THE UNIT RECEIVES. IT WAS DETERMINED THE PATIENT WAS PACED AT 60BPM AND THE MONITOR MEASURED THE QRS WHEN PATIENT WAS IN PEA. THE SPECIFIC ALARM THAT WAS ALLEGED TO NOT BE FUNCTIONING WAS THE ARTERIAL INVASIVE BLOOD PRESSURE. THE ALARM SETTING WAS FOUND ON TWO MONITORS, BUT IT REMAINS UNKNOWN HOW THIS CONFIGURATION WAS APPLIED. THE CONFIGURATION WAS REVIEWED, REVEALING THE EXTENDED ALARMS (RED ALARMS) WERE NEVER TURNED ON UNLESS THIS WAS MANUALLY CHANGED AT THE CUSTOMER SITE.
Patient problems: Insufficient Information
MAUDE report 24570978 ↗MalfunctionFeb 17, 2026Incorrect, Inadequate or Imprecise Result or Readings
PHILIPS RECEIVED A COMPLAINT ON AN INTELLIVUE MX500 PATIENT MONITOR INDICATING THAT THERE IS AN ISSUE WITH MONITORS NOT READING ECG ACCURATELY. 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 24366103 ↗MalfunctionFeb 9, 2026Defective Alarm
PHILIPS RECEIVED A COMPLAINT ON AN INTELLIVUE MX500 PATIENT MONITOR INDICATING THAT THE MONITOR IS NOT ALARMING WHEN A PATIENT DESATS; IT IS NOT READING O2 SATURATIONS. 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 24292980 ↗
Other MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) devices
- IntelliVue MX40 1.4GHz MX40 1.4 GHz Smart HoppingPhilips Medical Systems Hsg · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 recall47 deaths2,541 reports
- NA PU-621RNihon Kohden Corporation · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)17 deaths1,666 reports
- Tempus Pro 00-1024-RRemote Diagnostic Technologies Limited · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)7 recalls8 deaths1,217 reports
- NA PU-681RANihon Kohden Corporation · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)22 deaths1,493 reports
- IntelliVue Multi-Measurement Module X3 IntelliVue X3Philips Medizin Systeme Böblingen GmbH · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 recall19 deaths1,172 reports
- Patient Information Center IXPhilips Medical Systems Hsg · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)82 deaths941 reports
- Patient Information Center iXPhilips Medical Systems Hsg · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)83 deaths814 reports
- Tempus Pro 00-1024-RRemote Diagnostic Technologies Limited · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)5 recalls541 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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