IntelliVue MX550 Patient Monitor IntelliVue Patient Monitor MX550Recalls & reported problems
Philips Medizin Systeme Böblingen GmbH · The IntelliVue MX550 patient monitor is operated primarily via touch screen. It has an integrated 15" 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 MX550 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 portable and/or able to operate during short term power failures. · 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 MX550 patient monitor has 248 reports on file, with 12 deaths and 31 injuries. Many describe alarms that did not sound, and a few reports mention cardiac arrest, while others describe incorrect readings or missing audio prompts. There are 5 open recalls, covering monitors that did not alarm, a broken ground connection in a power supply, and software options or alarm features that were shipped or configured incorrectly.
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
- 256
- Deaths reported
- 12
- Injuries reported
- 32
- Recalls naming it
- 5
Summary
The FDA's MAUDE database contains 256 adverse event reports that list this exact device (DI 00884838038783), received between Feb 23, 2018 and Sep 23, 2026 — classified as 12 deaths, 32 injuries, 212 malfunctions.
The most frequently reported specific device problem is “No Audible Alarm” (98 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-0865-2026 · 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-1110-2025 · 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-2511-2024 · 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 Alarm98
- No Audible Prompt/Feedback35
- Defective Alarm26
- Device Alarm System18
- Incorrect Measurement17
- High Readings10
- Application Program Freezes or Fails to Launch8
- Imprecise or Erratic Results7
Patient problems
- No Clinical Signs, Symptoms or Conditions204
- Insufficient Information18
- No Known Impact Or Consequence To Patient10
- High Blood Pressure/ Hypertension8
- Cardiac Arrest6
- Asystole5
- Low Oxygen Saturation5
- No Patient Involvement4
Recent adverse event reports
The 25 most recent of 256 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026No Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873324 ↗InjurySep 18, 2026Defective Alarm
It was reported a red Desat alarm was not generated at the bedside or central station when the patient's SpO2 was in the 30's. The clinical specialist reviewed the clinical audit log, revealing SpO2 Desat alarms were generated and acknowledged. The staff reported no harm to the patient; however, good faith efforts were performed for clarification.
Patient problems: Low Oxygen Saturation
MAUDE report 50815897 ↗MalfunctionSep 16, 2026Imprecise or Erratic Results
Philips received a complaint on the IntelliVue MX550 Patient Monitor indicating there a variation with the NIBP. The device was in use at the time of the event. No adverse event occurred.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50790179 ↗MalfunctionSep 15, 2026High Readings
Philips received a complaint on the IntelliVue MX550 Patient Monitor indicating that a camera failure was reported and that the device displayed blood pressure readings that were higher than expected.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50771946 ↗MalfunctionSep 14, 2026High Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50765071 ↗MalfunctionSep 9, 2026No Audible Alarm
Philips received a complaint on the IntelliVue MX550 Patient Monitor indicating that the speaker was malfunctioning, and there was no audible sound. The device was not in use on a patient at the time of the event, so there was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50682044 ↗MalfunctionSep 8, 2026No Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50672455 ↗MalfunctionSep 2, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50573377 ↗MalfunctionSep 2, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50571797 ↗MalfunctionAug 28, 2026No Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50497166 ↗MalfunctionAug 10, 2026No Audible Alarm
Philips received a complaint on an IntelliVue MX550 Patient Monitor indicating there was a speaker malfunction. It was confirmed there was no audible sound produced. 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 50192901 ↗InjuryAug 5, 2026No Audible Alarm
Patient problems: Low Oxygen Saturation
MAUDE report 50145365 ↗MalfunctionAug 3, 2026No Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50114672 ↗MalfunctionJul 30, 2026Low Readings; Imprecise or Erratic Results
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50083161 ↗MalfunctionJul 28, 2026No Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50059551 ↗MalfunctionJul 27, 2026No Audible Prompt/Feedback
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50008193 ↗MalfunctionJul 27, 2026No Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50000745 ↗MalfunctionJul 20, 2026Imprecise or Erratic Results
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25878189 ↗MalfunctionJul 19, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25868179 ↗MalfunctionJul 16, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25847454 ↗MalfunctionJul 15, 2026No Audible Alarm
PHILIPS RECEIVED A COMPLAINT ON AN INTELLIVUE MX550 PATIENT MONITOR INDICATING THAT THERE WAS A SPEAKER MALFUNCTION ERROR. THERE WAS NO SOUND. THE DEVICE WAS NOT 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 25824588 ↗MalfunctionJul 13, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25808229 ↗MalfunctionJul 7, 2026No Audible Prompt/Feedback
PHILIPS RECEIVED A COMPLAINT ON THE INTELLIVUE MX550 PATIENT MONITOR INDICATING THAT THE DEVICE CAME UP WITH AN ERROR ON THE SPEAKER. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT, SO THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25741587 ↗MalfunctionJun 18, 2026Display or Visual Feedback Problem
PHILIPS RECEIVED A COMPLAINT ON AN INTELLIVUE MX550 PATIENT MONITOR INDICATING THAT NO RHYTHM WAS TRANSFERRING TO MONITOR; IT WAS FROZEN. IT WAS 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 25552384 ↗MalfunctionMay 29, 2026Imprecise or Erratic Results
PHILIPS RECEIVED A COMPLAINT ON INTELLIVUE MX550 PATIENT MONITOR INDICATING THAT THEY WERE GETTING WRONG NON-INVASIVE BLOOD PRESSURE (NIBP) VALUES. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. NO ADVERSE EVENT OR HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25332133 ↗
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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