Tempus Pro 00-1024-R (REF 867422)Recalls & reported problems

Summary

The FDA's MAUDE database contains 541 adverse event reports that list this exact device (DI 05060472442925), received between Jun 20, 2024 and Sep 30, 2026 — classified as 1 injury, 540 malfunctions.

The most frequently reported specific device problem is “Unable to Obtain Readings” (85 reports).

5 FDA recall records name this device's identifier, 5 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   Kit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated software and reintroducing the video laryngoscope issue (related to an August 2023 recall), which could lead to delay in diagnosis, delayed treatment, hypoxia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 ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 541 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Incorrect Measurement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950958 ↗
• MalfunctionSep 30, 2026Incorrect Measurement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950957 ↗
• MalfunctionSep 30, 2026Operating System Becomes Nonfunctional

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948929 ↗
• MalfunctionSep 30, 2026Failure to Charge

  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 device is not charging. The device was not in use on a patient at the time of the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948928 ↗
• MalfunctionSep 29, 2026Computer Operating System Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935990 ↗
• MalfunctionSep 29, 2026Mechanical Problem; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935987 ↗
• MalfunctionSep 22, 2026Device Sensing Problem

  Philips received a complaint concerning a Tempus Pro device. The customer reported that, upon powering on the device, the display remained blank despite the screen being backlit. The power button flashed green, and the monitor was unresponsive to user input and other commands. No patient impact, adverse event, or injury was reported in association with this issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50852455 ↗
• MalfunctionSep 21, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848515 ↗
• MalfunctionSep 21, 2026No Display/Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848514 ↗
• MalfunctionSep 21, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848513 ↗
• MalfunctionSep 11, 2026Operating System Becomes Nonfunctional

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50735390 ↗
• MalfunctionSep 10, 2026Poor Quality Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50713806 ↗
• MalfunctionSep 9, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50696579 ↗
• MalfunctionSep 9, 2026Unexpected Shutdown

  This report is based on information provided by a Philips Remote Service Engineer (RSE) and will be investigated by the Philips Complaint Handling Team. Philips received a complaint concerning a Tempus Pro device. It was reported that, upon startup, a screen appeared prompting the user to select ¿Abort Turn Off,¿ after which the device automatically powered off. As a result, a 12-lead ECG could not be obtained for a patient experiencing chest pain until a double-crewed ambulance (DCA) arrived with a LIFEPAK 15 (LP15) monitor/defibrillator. The Tempus Pro monitor was subsequently removed from service. The patient was transferred to another device, and alternative monitoring was implemented. No injury or adverse outcome was reported in association with this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50689012 ↗
• MalfunctionSep 7, 2026Failure to Calibrate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50657867 ↗
• MalfunctionSep 7, 2026Failure to Calibrate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50656848 ↗
• MalfunctionSep 7, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50652800 ↗
• MalfunctionSep 2, 2026Unable to Obtain Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50568860 ↗
• MalfunctionSep 2, 2026Failure to Charge; Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50564984 ↗
• MalfunctionAug 28, 2026Operating System Becomes Nonfunctional

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50508474 ↗
• MalfunctionAug 24, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50421119 ↗
• MalfunctionAug 24, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50421118 ↗
• MalfunctionAug 24, 2026Failure to Calibrate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50421117 ↗
• MalfunctionAug 24, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50420804 ↗
• MalfunctionAug 20, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50351706 ↗