Patient Information Center iX 4.5Recalls & reported problems
Philips Medizin Systeme Böblingen GmbH · Patient Information Center iX · Class 2
All models of Patient Information Center iX (9)
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.
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00884838127074), received between Dec 12, 2025 and Sep 17, 2026 — classified as 1 injury, 15 malfunctions.
The most frequently reported specific device problem is “No Audible Alarm” (4 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
- Dec 22, 2025Class IIOpen, Classified
A recent software (SW) patch modifies Mobile Event Notification filter settings without providing any indication to the user when upgrading the system.
Z-1156-2026 · Root cause: Software Design Change · Recall details · FDA record ↗
Most reported problems
Device problems
- No Audible Alarm4
- Wireless Communication Problem4
- Application Program Freezes or Fails to Launch2
- Defective Alarm1
- Device Alarm System1
- Display or Visual Feedback Problem1
- Insufficient Device Problem Information1
- Low Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions15
- Insufficient Information1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2026Low Readings
Philips received a complaint on a Patient Information Center iX indicating that the heartrate measurement for a patient was inaccurate (20-30 bpm). An MX40 was being used for ECG monitoring and when the accuracy was doubted, it was switched for an MP5; however, the heartrate was still low. Biomed tested both monitors and found both to be accurate. The patient was placed on an ECG cart for analysis, and the heartrate was found to be approximately 80 bpm. 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 50807601 ↗MalfunctionSep 1, 2026Application Program Freezes or Fails to Launch
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50548207 ↗MalfunctionAug 4, 2026Application Program Freezes or Fails to Launch
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50133776 ↗InjuryJun 18, 2026Insufficient Device Problem Information
PHILIPS RECEIVED A COMPLAINT ON THE PATIENT INFORMATION CENTER IX INDICATING THAT THE CUSTOMER REQUESTED ASSISTANCE PRINTING OFF DATA FOLLOWING AN UNSPECIFIED PATIENT HARM EVENT. REMOTE SERVICE ASSISTED THE CUSTOMER IN LOCATING AND PRINTING THE REQUESTED DATA. BIOMED CLEARLY INDICATED THERE WAS A PATIENT HARM; HOWEVER, THERE WAS NO INFORMATION ON THE CAUSE OR IF IT WAS RELATED TO THE DEVICE.
Patient problems: Insufficient Information
MAUDE report 25552029 ↗MalfunctionApr 3, 2026Device Alarm System
PHILIPS RECEIVED A COMPLAINT ON A PATIENT INFORMATION CENTER IX INDICATING THAT THE MONITOR IS NOT ALARMING AS EXPECTED FOR PVC. 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 24776783 ↗MalfunctionMar 31, 2026No Audible Alarm
PHILIPS RECEIVED A COMPLAINT ON THE PATIENT INFORMATION CENTER IX INDICATING THAT THE SOUND AT THE OVERVIEW STATION IS NOT WORKING. THE VOLUME SETTING IS AT 10; SYSTEM NOT AUDIO ALARMING FOR SOUNDS ON THE MONITOR. 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 24746965 ↗MalfunctionMar 11, 2026Wireless Communication Problem
PHILIPS RECEIVED A COMPLAINT ON A PATIENT INFORMATION CENTER IX INDICATING THAT ALL CENTRALS ARE IN LOCAL MODE. THE DEVICE WAS IN CLINICAL USE AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24573491 ↗MalfunctionFeb 24, 2026No Audible Alarm
IT WAS REPORTED THERE WAS NO MORE SOUND ON THE CENTRAL STATION SCREEN. 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 24426950 ↗MalfunctionFeb 16, 2026Wireless Communication Problem
IT WAS REPORTED THAT NO WAVEFORMS ARE COMING IN TO THE CENTRAL MONITOR. THE DEVICE WAS REPORTED TO BE IN CLINICAL USE. NO ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24356850 ↗MalfunctionFeb 16, 2026No Audible Alarm
THE BIOMED REPORTED THAT THERE IS NO AUDIO ON THE CENTRAL STATION. THE DEVICE WAS REPORTED TO BE IN CLINICAL USE. NO ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24343962 ↗MalfunctionJan 29, 2026No Audible Alarm
PHILIPS RECEIVED A COMPLAINT ON A PATIENT INFORMATION CENTER IX INDICATING THAT THERE WAS NO SOUND. 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 24214754 ↗MalfunctionJan 26, 2026No Audible Prompt/Feedback
IT WAS REPORTED THE DEVICE IS PRESENTED WITH A SPEAKER MALFUNCTION. PATIENT INVOLVEMENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT OR USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24177767 ↗MalfunctionDec 30, 2025Wireless Communication Problem; Wireless Communication Problem
PHILIPS RECEIVED A COMPLAINT ON THE PATIENT INFORMATION CENTER IX (PIC IX) INDICATING THAT THE 6TH, 7TH AND 8TH FLOOR MX40S ARE NOT CONNECTING TO CENTRAL STATION. THE WIRELESS TELEMETRY IS NOT PULLING VITALS. THE DEVICE WAS IN CLINICAL USE MONITORING PATIENTS AT TIME OF EVENT, NO ADVERSE EVENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23923556 ↗MalfunctionDec 24, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
PHILIPS RECEIVED A COMPLAINT ON A PATIENT INFORMATION CENTER IX INDICATING THAT THE SECTOR IS MAKING THE ECG LOOK LIKE IT IS SVT, BUT IT IS NOT. A PHILIPS REMOTE SERVICE ENGINEER (RSE) HAD THE PHILIPS CLINICAL SPECIALIST (CS) LOG INTO THE SYSTEM CONFIGURATION/LOCAL SURVEILLANCE/SCREEN CALIBRATION, USE A RULER TO MAKE THE LINE ON THE SCREEN MATCH A 1-INCH LINE ON THE RULER AND THEN CLICK OK. THE CS CHECKED THE MAIN SCREEN, BUT THERE WAS NO CHANGE. 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 23887969 ↗MalfunctionDec 23, 2025Defective Alarm; Defective Alarm
PHILIPS RECEIVED A COMPLAINT ON THE PATIENT INFORMATION CENTER IX INDICATING THAT THERE WAS A FAILURE OF THE CONTROL CENTER. FIRST THERE WERE NO MORE ALARM SOUNDS, THEN MORE AND MORE BEDS WENT AWAY, AND THE SCREEN WAS FROZEN. CONTROL NO LONGER WORKED. AFTER A COLD START BY OUR STANDBY, THE CONTROL CENTER STARTED UP AGAIN. ALL FUNCTIONS WERE BACK. SURVEILLANCE COULD BE CONTINUED. THE DEVICE WAS IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23880534 ↗MalfunctionDec 12, 2025Wireless Communication Problem; Wireless Communication Problem
PHILIPS RECEIVED A COMPLAINT ON A PATIENT INFORMATION CENTER IX (PIC IX) INDICATING THAT ALL TELEMETRY SIGNALS WERE LOST. 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 23794599 ↗
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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