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Patient Information Center iX 4.4Recalls & 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.

Quick summary

This Philips Patient Information Center iX has 87 reports in the FDA database, including 7 deaths and 3 injuries. Many reports describe alarms that do not sound and wireless communication failures, and some describe lost connectivity to central monitoring in cases where patients died. Reports rose to 73 in the past 12 months from 14 the year before. There is 1 open recall, started in July 2026, over software that may freeze and stop responding.

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
84
Deaths reported
7
Injuries reported
4
Recalls naming it
1

Summary

The FDA's MAUDE database contains 84 adverse event reports that list this exact device (DI 00884838127067), received between Jan 13, 2025 and Sep 29, 2026 — classified as 7 deaths, 4 injuries, 73 malfunctions.

The most frequently reported specific device problem is “No Audible Alarm” (28 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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 1 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 1 reportsJun 2025: 1 reportsJul 2025: 1 reportsAug 2025: 3 reportsSep 2025: 4 reportsOct 2025: 3 reportsNov 2025: 7 reportsDec 2025: 5 reportsJan 2026: 2 reportsFeb 2026: 9 reportsMar 2026: 9 reportsApr 2026: 5 reportsMay 2026: 9 reportsJun 2026: 4 reportsJul 2026: 6 reportsAug 2026: 8 reportsSep 2026: 6 reportsOct 2026: 0 reports2024202520269
Last 36 months. The most recent month may be incomplete.

Recalls naming this device

  1. Jul 31, 2026Class IIOpen, Classified

    Due to software malfunction, patient information system may freeze and become unresponsive.

    Z-3141-2026 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Device problems

  • No Audible Alarm28
  • Defective Alarm17
  • Wireless Communication Problem11
  • Device Alarm System6
  • Intermittent Communication Failure3
  • Adverse Event Without Identified Device or Use Problem2
  • Application Program Freezes or Fails to Launch2
  • Communication or Transmission Problem2

Patient problems

  • No Clinical Signs, Symptoms or Conditions75
  • Insufficient Information11
  • Fall1
  • Tachycardia1

Recent adverse event reports

The 25 most recent of 84 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 29, 2026Wireless Communication Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50938401 ↗
  • InjurySep 18, 2026No Audible Alarm

    Patient problems: Insufficient Information; Tachycardia

    MAUDE report 50828579 ↗
  • MalfunctionSep 16, 2026No Audible Alarm

    It was reported the audible alarms reset without user intervention. 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 50786254 ↗
  • InjurySep 15, 2026Device Alarm System

    Philips received a complaint on a indicating that on (b)(6) 2026, at approximately 2:52 PM to 2:53 PM, the patient located in bed UCCQ34 experienced an episode of ventricular fibrillation (VF). The episode ended at approximately 3:00 PM; however, the staff indicated that during the episode, the monitor did not issue a ventricular fibrillation alarm. Furthermore, in the subsequent review, no ventricular fibrillation alarm record was identified on either the bedside monitor or the PIC iX central unit. A shock was delivered to the patient who eventually recovered normal pulse. No other clinical information was provided.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50776598 ↗
  • DeathSep 15, 2026Adverse Event Without Identified Device or Use Problem

    It was reported the customer requested assistance in obtaining clinical audit logs following a patient death. There was impact to nursing and there was no allegation the device contributed to the patient's death. Engineering reviewed the logs, revealing system detected and annunciated the critical alarms as designed. Audit data confirms alarm generation, alarm notification, acknowledgement activity, and event documentation within the PIC iX system.

    Patient problems: Insufficient Information

    MAUDE report 50773140 ↗
  • MalfunctionSep 8, 2026Application Program Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50674613 ↗
  • MalfunctionAug 20, 2026Defective Alarm

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50346433 ↗
  • MalfunctionAug 13, 2026Wireless Communication Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50242679 ↗
  • DeathAug 12, 2026Wireless Communication Problem

    It was reported network connectivity was lost and the telemetry patient passed away. The audit logs revealed a loss of connectivity which resulted in a loss of central monitoring. The patient was then found deceased. The customer requested assistance reviewing the audit logs and testing of the device and network.

    Patient problems: Insufficient Information

    MAUDE report 50226749 ↗
  • MalfunctionAug 11, 2026Wireless Communication Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50201946 ↗
  • MalfunctionAug 10, 2026Defective Alarm

    Philips received a complaint on the Patient Information Center iX indicating that the red alarms are acknowledging themselves, turning off without interaction, may not be latched. Missed an asystole on a patient last night, red alarm canceled itself. 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 50196653 ↗
  • MalfunctionAug 10, 2026Application Program Freezes or Fails to Launch

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50192897 ↗
  • MalfunctionAug 4, 2026Intermittent Communication Failure

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50129064 ↗
  • MalfunctionAug 3, 2026Intermittent Communication Failure

    It was reported that following an unscheduled restart of the customer's servers at approximately 10:30 p.m. the previous evening, all patient monitoring units throughout the hospital restarted and reverted to local mode. After the monitors were returned to connected mode, communication issues affecting monitor retransmission to the central stations were observed across all departments and subsequently reported to the Biomedical Engineering Department.At approximately 1:30 a.m., the Biomedical Engineering Department performed several system restarts in an effort to resolve the issue. Following these actions, two departments experienced a condition in which none of the monitors were able to connect to the central monitoring system. The monitors displayed the message: "Central extension: assignment unavailable."The devices were reported to be in clinical use at the time of the event. No patient injury, user injury, or adverse event was reported.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50117498 ↗
  • DeathJul 30, 2026Defective Alarm

    It was reported the device did not generate an alarm for a change in patient condition and the patient passed away. The customer indicated there was no alarm or alarm history from 1pm to 4pm on the event date. The caregivers did not realize there was an issue until they entered the patient's room. Resuscitation was unsuccessful and the patient passed away.

    Patient problems: Insufficient Information

    MAUDE report 50090442 ↗
  • MalfunctionJul 28, 2026Defective Alarm

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50053037 ↗
  • MalfunctionJul 27, 2026Defective Alarm

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50043816 ↗
  • MalfunctionJul 22, 2026Wireless Communication Problem

    PHILIPS RECEIVED A COMPLAINT ON THE PATIENT INFORMATION CENTER IX INDICATING THAT SYSTEM PIC STATIONS LOST PATIENTS VITAL COMING ACROSS. 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 25906348 ↗
  • MalfunctionJul 22, 2026No Audible Alarm

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25900506 ↗
  • MalfunctionJul 21, 2026No Audible Alarm

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25884638 ↗
  • MalfunctionJun 26, 2026Device Sensing Problem

    CUSTOMER REPORTED THAT THE SEVERAL BED AREAS HAVE BEEN ENTERING STANDBY MODE OR LEAVING STANDBY MODE WITHOUT ANY USER INTERACTION OR PATIENT MONITORING. 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 25643367 ↗
  • MalfunctionJun 24, 2026No Display/Image

    PHILIPS RECEIVED A COMPLAINT ON A PATIENT INFORMATION CENTER IX INDICATING THAT THE CENTRAL MONITOR SCREEN IS BLACK AND NO VITALS ARE SHOWN. 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 25612363 ↗
  • MalfunctionJun 18, 2026Communication or Transmission Problem

    PHILIPS RECEIVED A COMPLAINT ON A PATIENT INFORMATION CENTER IX INDICATING THAT THEY LOST ALL SOUTH CONNECTION; THE PRIMARY SERVER REBOOTED POTENTIALLY. 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 25548251 ↗
  • MalfunctionJun 2, 2026Wireless Communication Problem

    PHILIPS RECEIVED A COMPLAINT ON THE PATIENT INFORMATION CENTER IX INDICATING THAT THEY LOST MONITORING WITHOUT ALARM. 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 25361743 ↗
  • MalfunctionMay 28, 2026No Audible Alarm

    IT WAS REPORTED THAT THERE WAS NO AUDIBLE SIGNAL FROM THE CENTRAL STATION REGARDING A VENTRICULAR TACHYCARDIA (VTACH) EVENT. 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 25319048 ↗

Other Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) devices

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Sources and updates

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