Tempus Pro 00-1024-R (UDI 05060472441027)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,217 adverse event reports that list this exact device (DI 05060472441027), received between Oct 27, 2021 and Sep 15, 2026 — classified as 8 deaths, 16 injuries, 1,193 malfunctions.

The most frequently reported specific device problem is “Unable to Obtain Readings” (228 reports).

7 FDA recall records name this device's identifier, 7 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Nov 26, 2025Open, Classified

   Patient monitor measures Intracranial Pressure (ICP) and Bladder Pressure (BDR) but ICP and BDR measurements have not been tested or validated for accuracy. If healthcare providers base clinical judgment on unvalidated measurements, this could potentially lead to incorrect clinical decisions.

   Z-1027-2026 · Root cause: Device Design · FDA record ↗

2. May 30, 2025Open, Classified

   Kit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated software and reintroducing the video laryngoscope issue (related to an August 2023 recall), which could lead to delay in diagnosis, delayed treatment, hypoxia due to unexpected loss of video laryngoscopy and all other monitor measurements during system restart.

   Z-2175-2025 · Root cause: Software change control · FDA record ↗

3. Apr 16, 2025Open, Classified

   software issue that causes an error screen on a portable vital signs monitor when attaching video Laryngoscope.

   Z-1666-2025 · Root cause: Device Design · FDA record ↗

4. Apr 15, 2025Open, Classified

   Patient Monitor software update to address issues:1)May freeze at startup with MPM Application error and Attention Restart Required messages,2)Monitor may freeze and reboot at start of 12-lead ECG or after, 3)May reboot after intermittent connection with Smart Mount, 4) 12-lead ECG measurements with Louvain algorithm and software before vx.36 could produce inaccurate rhythm/morphology statements.

   Z-1729-2025 · Root cause: Software design · FDA record ↗

5. Aug 24, 2023Open, Classified

   Full screen error message may occur on patient monitors with affected hardware version, either during or after laryngoscopes are unplugged from monitors, informing users a 60-100 second shutdown/restart are required. Error prevents: viewing graphical patient vital signs, sounding of pulse audio tone, visualization of patient airway used during intubation; may lead to treatment delay or hypoxia.

   Z-2625-2023 · Root cause: Device Design · FDA record ↗

6. Feb 23, 2023Open, Classified

   During internal testing, Regulatory Compliance issues were identified regarding the Monitor and Power Supplies for fluid ingress and basic safety issues.

   Z-1321-2023 · Root cause: Under Investigation by firm · FDA record ↗

7. May 25, 2021Open, Classified

   The Tempus Pro (Trizeps 7 only) when used in combination with a specified laryngoscope device can cause two error types when subsequently unplugged.

   Z-1997-2021 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 1,217 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Erratic or Intermittent Display

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50780991 ↗
• MalfunctionSep 11, 2026Wireless Communication Problem

  This report is based on information provided by Philips Remote Service personnel and will be investigated by the Philips Complaint Handling Team. Philips received a complaint on the Tempus Pro indicating that during log file analysis, a previously unknown/unreported network connection error was discovered. A request for additional information regarding the incident has been sent and the response is not yet received. No known patient or user impact occurred as a result of this incident.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50731352 ↗
• MalfunctionSep 3, 2026Failure to Transmit Record

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50596353 ↗
• MalfunctionSep 2, 2026Display or Visual Feedback Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50568862 ↗
• MalfunctionSep 1, 2026Wireless Communication Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50554031 ↗
• MalfunctionAug 26, 2026Unable to Obtain Readings; Failure to Calibrate

  This report is based on information provided by a Third Party Bench Engineer and has been investigated by the Philips Complaint Handling Team. Philips received a complaint on the Tempus Pro indicating that the device capnometer would not calibrate or read the CO2 correctly There was no reported patient involvement, therefore no health consequences or impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50458173 ↗
• MalfunctionAug 21, 2026Failure to Transmit Record

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50380550 ↗
• MalfunctionAug 21, 2026Fitting Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50380316 ↗
• MalfunctionAug 19, 2026Unable to Obtain Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50333622 ↗
• MalfunctionJul 27, 2026Fracture

  This report is based on information provided by a Philips Bench Engineer and has been investigated by the Philips Complaint Handling Team. Philips received a complaint on the Tempus Pro indicating that while the device was removed from service at the Third-Party Bench Service Repair the charging port was discovered to be physically damaged with the center pin missing. As the device was removed from service at the time of the event, there was no patient involvement, therefore no health consequences or impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50046461 ↗
• MalfunctionJul 21, 2026Wireless Communication Problem

  This report is based on information provided by Philips Remote Service personnel and has been investigated by the Philips Complaint Handling Team. Philips received a complaint on the Tempus Pro indicating that during a medical intervention after recording a 12-Lead Electrocardiogram (ECG), when attempting to send the ECG to the cardio center, the device indicated the cell phone module was malfunctioning. The user restarted the device; however this did not resolve the issue. o patient or user harm occurred as a result of this incident.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25891817 ↗
• MalfunctionJul 20, 2026Wireless Communication Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25883145 ↗
• MalfunctionJul 20, 2026Erratic or Intermittent Display; Failure to Calibrate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25881501 ↗
• MalfunctionJun 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS REMOTE SERVICE PERSONNEL AND WILL BE INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THAT THE CAPNOGRAPHY CURVE IS RUNNING AND CAPNOGRAPHY VALUES (17, 22, 30, ETC.) WERE DISPLAYING ON THE MONITOR, HOWEVER CAPNOGRAPHY WAS NOT CONNECTED AND THE CAPNOGRAPHY INPUT COVER WAS CLOSED. A REQUEST FOR ADDITIONAL INFORMATION REGARDING THE INCIDENT HAS BEEN SENT AND THE RESPONSE IS NOT YET RECEIVED. THERE WAS NO REPORT OF ACTUAL HARM REPORTED WITH THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25669537 ↗
• MalfunctionJun 29, 2026Computer Operating System Problem

  This report is based on information provided by Philips Remote Service personnel and has been investigated by the Philips Complaint Handling Team. Philips received a complaint on the Tempus Pro indicating that at the beginning of the users shift, when turning on the monitor, the main screen froze and wouldn't respond to clicks on New Patient, the screen or turning off with the green power button. The monitor subsequently restarted itself but took longer than usual to load to the main screen. Following this restart, the device was functional. When powering off, a small black box with an error message appeared, however the user does not recall what the error message stated and an image of the error was not taken. During the incident, the device beeped three times, but the tone of the beeping was observed to be different than expected. The user removed the device from service. As the incident occurred during shift change, there was no patient involvement at the time of the incident, no harm or impact occurred.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25654366 ↗
• MalfunctionJun 23, 2026Unintended Application Program Shut Down

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS REMOTE SERVICE PERSONNEL AND WILL BE INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THAT AN UNEXPECTED RESTART OF THE DEVICE WAS DISCOVERED WHILE PERFORMING A DEVICE LOG FILE ANALYSIS. THIS RESTART OCCURRED DURING A MEDICAL INTERVENTION HOWEVER NO HARM OCCURRED TO THE PATIENT AS A RESULT OF THE INCIDENT. A REQUEST FOR ADDITIONAL INFORMATION REGARDING THE INCIDENT HAS BEEN SENT AND THE RESPONSE IS NOT YET RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25593978 ↗
• MalfunctionJun 3, 2026Wireless Communication Problem

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS REMOTE SERVICE PERSONNEL AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THAT DURING A MEDICAL INTERVENTION A SIGNAL OUTAGE OCCURRED. DURING THE INCIDENT, THE USER REBOOTED THE DEVICE IN AN ATTEMPT TO RESOLVE; HOWEVER, THE UNAVAILABLE NETWORK SIGNAL PERSISTED. THE AMBULANCE WAS REPOSITIONED WITH NO EFFECT. APPROXIMATELY 30 MINUTES INTO THE SIGNAL OUTAGE, IT WAS OBSERVED THAT THE SIGNAL WAS AVAILABLE AGAIN. INFORMATION OBTAINED THROUGH GOOD FAITH EFFORT INDICATED NO HARM OR IMPACT OCCURRED.

  Patient problems: Myocardial Infarction; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25385481 ↗
• MalfunctionMay 26, 2026Unable to Obtain Readings

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY REMOTE SERVICE ENGINEER RSE AND IS CURRENTLY UNDER INVESTIGATION BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO , INDICATING THAT THE DEVICE WAS UNABLE TO DISPLAY AN EKG. THE DEVICE WAS NOT IN CLINICAL USE, THEREFORE NO PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25281928 ↗
• MalfunctionApr 20, 2026Unexpected Shutdown; Unintended Application Program Shut Down

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS REMOTE SERVICE PERSONNEL AND WILL BE INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THAT DURING A MEDICAL TRANSPORT OF A PATIENT, THE TEMPUS PRO MONITOR UNEXPECTEDLY RESTARTED. INFORMATION OBTAINED THROUGH GOOD FAITH EFFORT INDICATED NO PATIENT HARM OCCURRED AS A RESULT OF THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24933023 ↗
• MalfunctionApr 16, 2026Erratic or Intermittent Display

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS REMOTE SERVICE PERSONNEL AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THAT THE TOUCHSCREEN WAS EXPERIENCING A CALIBRATION ISSUE. INFORMATION OBTAINED THROUGH GOOD FAITH EFFORT INDICATED THE REPORTED PROBLEM OCCURRED WHILE THE DEVICE WAS REMOVED FROM SERVICE FOR PREVENTATIVE MAINTENANCE. NO PATIENT WAS INVOLVED IN THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24900497 ↗
• MalfunctionMar 30, 2026Computer Operating System Problem; Operating System Becomes Nonfunctional

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS REMOTE SERVICE PERSONNEL AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THAT DURING A MEDICAL INTERVENTION; WHILE RECORDING AND ATTEMPTING TO SEND THE 12-LEAD ELECTROCARDIOGRAM (ECG) TO (B)(6) CENTER, THE DEVICE MADE A SOUND, BEGAN A STARTUP TEST AND THEN FROZE. THE DEVICE WOULD NOT RESPOND. INFORMATION OBTAINED THROUGH GOOD FAITH EFFORT INDICATED THE 12-LEAD ECG WAS SUCCESSFULLY SENT DURING THE INCIDENT. NO HARM OR IMPACT OCCURRED TO THE PATIENT DURING THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24718174 ↗
• MalfunctionMar 20, 2026Fracture

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY A PHILIPS REMOTE SERVICE ENGINEER AND A BENCH ENGINEER AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THAT THE CAPNOMETER DOOR WAS BROKEN. THERE WAS PATIENT INVOLVEMENT, HOWEVER NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24654957 ↗
• MalfunctionMar 17, 2026Incorrect Measurement

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS REMOTE SERVICE PERSONNEL AND WILL BE INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THAT DURING A MEDICAL INTERVENTION WHILE MONITORING PATIENT'S UNSTABLE BLOOD CIRCULATION; AFTER THE USER CONNECTED ETCO2 (CAPNOGRAPHY), THE CAPNOGRAPH SHOWED DIFFERENT VALUES (10, 0, 70). USER ATTEMPTED TO TROUBLESHOOT BY CONNECTING A SECOND ETCO2 SENSOR, BUT ISSUE PERSISTED. INFORMATION OBTAINED WITHIN GOOD FAITH EFFORT INDICATED SENSORS WERE PROPERLY CONNECTED TO THE MONITOR AND AIRWAY CIRCUIT AND WERE OPERATING UNDER SPECIFIED TEMPERATURE AND HUMIDITY RANGE. BOTH SENSORS WERE INDICATED TO BE NEW. NO ALARMS OR MESSAGES OCCURRED. SENSORS WERE STORED IN ORIGINAL BAG(S) PRIOR TO USE. A LARYNGEAL MASK AIRWAY (LMA) WAS USED. AFTER CONNECTING TO THE RENDEZVOUS MONITOR, ETCO2 THEN SHOWED STABLE VALUES. THERE WAS NO REPORT OF ACTUAL HARM REPORTED WITH THIS COMPLAINT.

  Patient problems: Hemodynamic instability; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24623701 ↗
• MalfunctionMar 13, 2026Signal Artifact/Noise

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS REMOTE SERVICE PERSONNEL AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THAT DURING PATIENT TRANSPORT FROM PRAGUE, A PATIENT WITH AN ICD (IMPLANTABLE CARDIOVERTER DEFIBRILLATOR) WAS MONITORED USING ECG3 ON THE TEMPUS PRO MONITOR. THE DEVICE REPEATEDLY DISPLAYED FIKO AND ASYSTOLE ALARMS LASTING APPROXIMATELY 30 TO 160 SECONDS. THE MONITOR DISPLAYED A FIKO ALERT, WHICH INDICATES POOR ECG SIGNAL QUALITY OR LEAD CONTACT INTERFERENCE THAT MAY RESULT IN UNRELIABLE RHYTHM INTERPRETATION AND POTENTIAL ARTIFACT-RELATED ALARMS. THE PATIENT REMAINED CONSCIOUS AND COMMUNICATIVE THROUGHOUT THE EVENTS AND DID NOT RECEIVE ANY ICD SHOCKS. NO CLINICAL SIGNS OF ARRHYTHMIA WERE REPORTED, AND THE EVENTS WERE ASSESSED AS ECG ARTIFACT RESULTING IN UNRELIABLE CARDIAC MONITORING DURING TRANSPORT. INFORMATION OBTAINED THROUGH GOOD FAITH EFFORT INDICATED THERE WAS NO REPORT OF ACTUAL HARM REPORTED WITH THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24589185 ↗
• MalfunctionFeb 23, 2026Erratic or Intermittent Display; Calibration Problem

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY A PHILIPS BENCH ENGINEER AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THAT THE DEVICE DISPLAY (TOUCHSCREEN) WOULD NOT HOLD CALIBRATION DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT, THEREFORE NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24420215 ↗