Tempus Pro 00-1004-R (REF 867420)Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 05060472442901), received between Apr 25, 2025 and Sep 30, 2026 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Break” (7 reports).

4 FDA recall records name this device's identifier, 4 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. 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 ↗

3. 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 ↗

4. 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 ↗

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Computer Software Problem; Unexpected Shutdown

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950624 ↗
• MalfunctionSep 23, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50874042 ↗
• MalfunctionSep 23, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873063 ↗
• MalfunctionSep 18, 2026Operating System Becomes Nonfunctional

  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 following the application of a software update, the device does not boot up. As the device was removed from service to perform a software update, there was no patient involvement at the time of the incident.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50825336 ↗
• MalfunctionJul 27, 2026Display or Visual Feedback Problem; Calibration Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50000555 ↗
• MalfunctionJun 9, 2026Break

  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 WHILE THE DEVICE WAS REMOVED FROM SERVICE WHEN A PHYSICALLY DAMAGED DIRECT CURRENT (DC) CHARGING PORT WAS DISCOVERED. AS THE DEVICE WAS REMOVED FROM SERVICE AT THE TIME OF THE EVENT, NO PATIENT OR USER HARM OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25450489 ↗
• MalfunctionJun 5, 2026Break

  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 WHILE THE DEVICE WAS REMOVED FROM SERVICE WHEN A PHYSICALLY DAMAGED DIRECT CURRENT (DC) CHARGING PORT WAS DISCOVERED. AS THE DEVICE WAS REMOVED FROM SERVICE AT THE TIME OF THE EVENT, NO PATIENT OR USER HARM OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25410918 ↗
• MalfunctionMay 20, 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 AFTER STARTING UP, THE ECG (ELECTROCARDIOGRAM) WAS DISPLAYED AS DISABLED. THERE WAS NO REPORTED HARM NOR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25234535 ↗
• MalfunctionMay 18, 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 THE ECG (ELECTROCARDIOGRAM) WAS DISABLED. THERE WAS NO IMPACT TO THE PATIENT AND NO HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25209441 ↗
• MalfunctionFeb 5, 2026Unintended Application Program Shut Down

  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 INVOLVING A TEMPUS PRO DEVICE IN WHICH, AFTER RECORDING A 12 LEAD ECG AND TRANSMITTING IT TO THE (B)(6) CARDIOCENTER, THE DEVICE EMITTED A BEEP, AND THE TEMPUS MONITOR SPONTANEOUSLY RESTARTED. THE DEVICE WAS IN USE DURING THIS EVENT, HOWEVER, NO PATIENT WAS IMPACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24272641 ↗
• MalfunctionJan 16, 2026Unexpected Shutdown

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS REMOTE SERVICE ENGINEER RSE AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING DURING DIAGNOSIS, THE DEVICE SUDDENLY SHUT DOWN AT 15% BATTERY. THERE WAS NO REPORTED IMPACT TO THE PATIENT, BUT THE DEVICE WAS UNAVAILABLE DELAYING DIAGNOSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24098915 ↗
• MalfunctionDec 12, 2025Operating System Becomes Nonfunctional; Operating System Becomes Nonfunctional

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY REMOTE SERVICE ENGINEER RSE, A SERVICE ENGINEER AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THE DEVICE WHEN POWERED ON, THE RDT BOOTUP SCREEN WILL LOAD, BUT THEN STOPS PROGRESSING. THERE WERE NO REPORTS OF HARM ALLEGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23794739 ↗
• MalfunctionDec 2, 2025Wrong Label; Wrong Label

  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 REGARDING THE TEMPUS PRO, INDICATING A DEVICE SERIAL NUMBER MISMATCH. THE DEVICE WAS NOT IN USE DURING THIS EVENT, THEREFORE NO PATIENT OR USER WAS HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23690963 ↗
• MalfunctionSep 9, 2025Failure to Charge; Failure to Charge

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS REGULATORY AFFAIRS TEAM AND WILL BE INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT VIA A USER REPORT ON THE TEMPUS PRO INDICATING THAT USING THE SIDE CHARGING PORT LEADS TO CHARGING SOCKET FAILURE. A REQUEST FOR ADDITIONAL INFORMATION REGARDING THE INCIDENT AND POTENTIAL PATIENT INVOLVEMENT HAS BEEN SENT AND THE RESPONSE IS NOT YET RECEIVED. THERE WAS NO REPORT OF ACTUAL HARM ASSOCIATED WITHIN THE INCIDENT DESCRIPTION OF THE USER REPORT, HOWEVER, AN ANNEX F CODE OF A DELAY IN DIAGNOSIS WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED TO CONFIRM THE DISCREPANCY AND PROVIDE ADDITIONAL EVENT DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23000085 ↗
• MalfunctionSep 2, 2025Failure to Charge; Fracture; Failure to Charge; Fracture

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY A PHILIPS TECHNICAL ENGINEER AND WILL BE INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THAT THE DEVICE CHARGING PORT WAS DAMAGED AND WAS NOT CHARGING. THERE WAS NO REPORTED PATIENT INVOLVEMENT, THEREFORE NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22931037 ↗
• MalfunctionAug 1, 2025Unexpected Shutdown; Unexpected Shutdown

  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 PATIENT EVENT, THE TEMPUS PRO WOULD NOT STAY POWERED ON. THE BATTERY APPEARED TO BE PROPERLY SEATED AND THE DEVICE WOULD POWER ON, BUT AFTER A FEW SECONDS WOULD LOSE POWER. IT WAS NOTED THE BATTERY WOULD NOT STAY SEATED IN THE DEVICE. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT, HOWEVER NO PATIENT OR USER HEALTH CONSEQUENCES OR HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22687798 ↗
• MalfunctionJul 29, 2025Break; Unable to Obtain Readings; Break; Unable to Obtain Readings

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY A PHILIPS REMOTE SERVICE ENGINEER AND WILL BE INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THAT THE DEVICE ETCO2 (END TIDAL CARBON DIOXIDE) INTERNAL PORT WAS DAMAGED AND NOT FUNCTIONING. THERE WAS NO REPORTED PATIENT INVOLVEMENT, THEREFORE NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22652886 ↗
• MalfunctionJul 10, 2025Operating System Becomes Nonfunctional; Operating System Becomes Nonfunctional

  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 THE DEVICE IS UNABLE TO BOOT- STUCK ON RDT STARTING SCREEN. THE CUSTOMER REPORTED IT IS NOT POSSIBLE TO MAKE THE DEVICE BOOT AT ALL. THE CUSTOMER TRIED WITH USB(UNIVERSAL SERIAL BUS) AND OPENING THE DEVICE TO CHECK FOR FAULTS. THERE WAS NO PATIENT INVOLVEMENT AND NO IMPACT ALLEGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22468623 ↗
• MalfunctionJul 1, 2025Failure to Charge; Failure to Charge

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY A PHILIPS REMOTE SERVICE ENGINEER AND WILL BE INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THAT THE DEVICE WAS NOT CHARGING FROM THE MAINS SUPPLY. THERE WAS NO REPORTED PATIENT INVOLVEMENT, THEREFORE NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22375035 ↗
• MalfunctionJun 10, 2025Break; Break

  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 BENCH ANALYSIS IT WAS DISCOVERED THAT THE TACTICAL SWITCH WAS DAMAGED. AS THE EMERGENT ISSUE WAS DISCOVERED DURING ANALYSIS, THERE WAS NO PATIENT INVOLVEMENT. THEREFORE NO PATIENT OR USER HEALTH CONSEQUENCES OR IMPACT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22180720 ↗
• MalfunctionMay 19, 2025Battery Problem; Battery 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 AN UNSPECIFIED ISSUE WITH THE BATTERY AND A REPAIR IS NEEDED. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE EVENT, THEREFORE NO PATIENT OR USER HEALTH CONSEQUENCES OR IMPACT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22047605 ↗
• MalfunctionApr 29, 2025Break; Unable to Obtain Readings; Break; Unable to Obtain Readings

  IT HAS BEEN REPORTED TO PHILIPS THAT THE DEVICE ECG PATIENT CABLE WAS BROKEN OFF WHILST CONNECTED INTO THE ECG PORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21925054 ↗
• MalfunctionApr 25, 2025Display or Visual Feedback Problem; Display or Visual Feedback 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 THE TOUCH SCREEN WAS EXPERIENCING AN INTERMITTENT MALFUNCTION. THE DEVICE WAS RESTARTED AND RECALIBRATED, BUT THE ISSUE REMAINS. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE EVENT, THEREFORE NO PATIENT OR USER HEALTH CONSEQUENCES OR IMPACT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21913029 ↗