Tempus Pro 00-1007-R (REF 867421)Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 05060472442918), received between Mar 28, 2025 and Sep 30, 2026 — classified as 64 malfunctions.

The most frequently reported specific device problem is “Break” (11 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   Kit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated software and reintroducing the video laryngoscope issue (related to an August 2023 recall), which could lead to delay in diagnosis, delayed treatment, hypoxia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 64 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Crack

  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 during configuration of device, the display was observed to have a large crack in it. There were no reports of harm nor impact at this time.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50944801 ↗
• MalfunctionSep 29, 2026Failure to Charge

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938829 ↗
• MalfunctionSep 28, 2026Failure to Charge

  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 device is not charging. There was no patient or user impact was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916298 ↗
• MalfunctionSep 23, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872600 ↗
• MalfunctionSep 22, 2026Degraded

  Philips received a complaint concerning a Tempus Pro device in which the Universal Serial Bus (USB) port was reported to be nonfunctional. No patient involvement was reported in association with this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50853096 ↗
• MalfunctionSep 22, 2026Material Twisted/Bent

  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 regarding a Tempus Pro device, indicating that the Alternating Current (AC) charging pin is bent, preventing the main unit from charging. No patient involvement was reported in connection with this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50852461 ↗
• MalfunctionSep 17, 2026Failure to Calibrate

  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 capnometer calibration failed. There was no reported patient involvement, therefore no health consequences or impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50803960 ↗
• MalfunctionSep 11, 2026Failure to Charge

  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 charging port was not working. The device use at the time of the event is unknown; however there was no patient or user harm has been reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50736521 ↗
• MalfunctionSep 10, 2026No Tactile Prompts/Feedback

  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 touch was inaccurate. The bench engineer confirmed the touch issues caused by physical damage to the screen protector. Once the Bench Engineer removed the screen protector, there are no longer any touch issues. However, there is an observed dent in the display, so replacement of the display is recommended. There was no impact to the patient and no harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50718797 ↗
• MalfunctionSep 9, 2026Break; Charging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50695625 ↗
• MalfunctionSep 9, 2026Break; Charging Problem

  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 charging port had a snapped pin from the main board. There was no reported patient involvement, therefore no health consequences or impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50694721 ↗
• MalfunctionAug 21, 2026Unintended Application Program Shut Down

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50383607 ↗
• MalfunctionAug 20, 2026Unable to Obtain Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50354577 ↗
• MalfunctionAug 20, 2026Unable to Obtain Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50352629 ↗
• MalfunctionAug 13, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50235929 ↗
• MalfunctionAug 3, 2026Key or Button Unresponsive/not Working

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50112055 ↗
• MalfunctionJul 27, 2026Operating System Becomes Nonfunctional; Operating System Version or Upgrade Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50019687 ↗
• MalfunctionJul 15, 2026Unable to Obtain Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25828165 ↗
• MalfunctionJun 12, 2026Erratic or Intermittent Display

  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 REMOVED FROM SERVICE AT THIRD-PARTY BENCH SERVICE, THE THIRD-PARTY SERVICE ENGINEER OBSERVED THE TEMPUS PRO TOUCHSCREEN INPUTS ARE INACCURATE. A TOUCHSCREEN CALIBRATION WAS PERFORMED, BUT THE ISSUE WAS NOT RESOLVED. AS THE DEVICE WAS REMOVED FROM SERVICE AT THE TIME OF THE INCIDENT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25491432 ↗
• MalfunctionJun 8, 2026Erratic or Intermittent Display

  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 UNABLE TO SELECT A SECTION ON THE TOUCHSCREEN/DISPLAY EVEN AFTER CALIBRATION ATTEMPTS. THERE WAS NO REPORTED PATIENT INVOLVEMENT, THEREFORE NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25437197 ↗
• MalfunctionJun 4, 2026Operating System Becomes Nonfunctional

  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 BOOTING SATISFACTORILY. WHILST WITH A PATIENT CONFIGURING THE DEVICE, WHEN THE MONITOR WAS TURNED ON, NO MONITORING APPEARED ALTHOUGH THE BATTERY WAS FULL. THE DEVICE WAS TURNED OFF AND ON AGAIN AND THEN THE SCREEN WENT BLANK, THEN HAD WHITE LINES ACROSS IT, AFTER IT PASSED THAT STAGE THE TOUCHSCREEN WAS NOT FUNCTIONING. THERE WAS PATIENT INVOLVEMENT, HOWEVER NO REPORTED HEALTH CONSEQUENCES OR IMPACT. ANOTHER ALTERNATE DEVICE WAS USED FOR PATIENT MONITORING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25400866 ↗
• MalfunctionJun 2, 2026Operating System Becomes Nonfunctional

  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 PASSING THE BOOT UP PHASE. THERE WAS NO REPORTED PATIENT INVOLVEMENT, THEREFORE NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25363214 ↗
• MalfunctionMay 27, 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 25304475 ↗
• MalfunctionMay 27, 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 25304273 ↗
• MalfunctionMay 14, 2026Unable to Obtain Readings

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY FIELD SERVICE ENGINEER FSE AND IS CURRENTLY UNDER INVESTIGATION BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING WHEN PERFORMING A DAILY CHECK, THE CO2 REMAINS IN PRE-HEATING MODE FOR EXTENDED PERIOD OF TIME FOLLOWED BY THE "CAPNO DISABLED" ERROR. THERE WAS NO IMPACT TO PATIENT AND NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25174599 ↗