PHILIPS IntelliVue MX600 patient monitor 865242Recalls & reported problems
Philips Medizin Systeme Böblingen GmbH · 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.
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00884838029095), received between Sep 27, 2019 and Aug 15, 2023 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Defective Alarm” (1 report).
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.
Recalls naming this device
- Oct 31, 2025Class IIOpen, Classified
Potential issue where the IntelliVue monitors did not alarm.
Z-0866-2026 · Root cause: Use error · Recall details · FDA record ↗
Most reported problems
Device problems
- Defective Alarm1
- Defective Component1
- Incorrect Measurement1
- No Audible Prompt/Feedback1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Patient Involvement1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 15, 2023No Audible Prompt/Feedback; No Audible Prompt/Feedback
THE CUSTOMER REPORTED THE DEVICE DISPLAYS A SPEAKER MALFUNCTION ERROR MESSAGE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT, THERE WAS NO PATIENT INVOLVEMENT. PHILIPS PERFORMED REMOTE DIAGNOSTIC TESTING, THE DEVICE WAS REBOOTED WHICH DID NOT RESOLVE THE ISSUE. THE NEXT STEPS RECOMMENDED WERE ON-SITE REPAIR TO TROUBLESHOOT THE SPEAKER AND MOTHERBOARD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17548818 ↗MalfunctionJan 31, 2022Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THAT THEY FOUND THE O2 SATURATION MEASUREMENT TO BE NOT ACCURATE. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, BUT NO ADVERSE EVENT TO PATIENT OR USER WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13401455 ↗MalfunctionOct 28, 2021Defective Alarm; Defective Alarm
THE CUSTOMER REPORTED THAT THE BLOOD OXYGEN PARAMETERS CAN'T ALARM NORMALLY. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF EVENT, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12712697 ↗MalfunctionSep 27, 2019Defective Component
THE CUSTOMER REPORTED A SPEAKER MALFUNCTION. NO ADVERSE EVENT INVOLVING A PATIENT OR USER WAS REPORTED.
Patient problems: No Patient Involvement
MAUDE report 9130042 ↗
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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