Tempus Pro 00-1007-R (UDI 05060472440013)Recalls & reported problems

Summary

The FDA's MAUDE database contains 114 adverse event reports that list this exact device (DI 05060472440013), received between Dec 22, 2022 and Nov 3, 2025 — classified as 114 malfunctions.

The most frequently reported specific device problem is “Failure to Charge” (19 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   Kit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated software and reintroducing the video laryngoscope issue (related to an August 2023 recall), which could lead to delay in diagnosis, delayed treatment, hypoxia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 114 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2025Unable to Obtain Readings; Unable to Obtain Readings

  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 WHILE BENCH ENGINEER WAS PERFORMING DEVICE ANALYSIS THE DEVICE FAILED FUNCTIONAL TESTING WITH ELECTROCARDIOGRAM (ECG) LEADS. AS THE DEVICE WAS REMOVED FROM SERVICE AT THE TIME OF THE EVENT, THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT. NO PATIENT OR USER HEALTH CONSEQUENCES OR IMPACT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23457359 ↗
• MalfunctionJun 30, 2025Charging Problem; Charging Problem

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS 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 ROUTINE INSPECTION, IT WAS NOTED THAT THE AC (ALTERNATE CURRENT) POWER ENTRY PORT HAD BEEN DAMAGED. THERE WAS NO RECORD OF HOW THE DAMAGE HAPPENED BUT WAS NOTED THAT THE AC (ALTERNATE CURRENT) POWER CORD WILL NOT SEAT IN THE PORT. AS SUCH, THE DEVICE CANNOT BE CHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22365627 ↗
• MalfunctionJun 24, 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 WILL NOT LAUNCH PAST CANNOT LOCATE MPM APPLICATION.EXE - RE-APPLY LATEST SOFTWARE UPDATE ERROR. THERE WAS NO IMPACT NOR HEALTH CONSEQUENCES NOTED, HOWEVER, IT IS UNKNOWN AT THIS TIME IF THE DEVICE WAS IN USE. A GOOD FAITH EFFORT HAS BEEN INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22318483 ↗
• MalfunctionMay 19, 2025Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED TO PHILIPS THAT THE CAPNOMETER WAS MALFUNCTIONING AND THERE WAS NO CO2 MEASUREMENT. THE ISSUE WAS FOUND DURING BENCH REPAIR. NO USER OR PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22042941 ↗
• MalfunctionMay 12, 2025Failure to Charge; Fracture; Failure to Charge; Fracture

  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 CENTRAL PIN IS DAMAGED. THERE WAS NO REPORTED PATIENT INVOLVEMENT, THEREFORE NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22004267 ↗
• MalfunctionMay 9, 2025Erratic or Intermittent Display; Failure to Calibrate; Inappropriate Tactile Prompt/Feedback; Erratic or Intermittent Display; Failure to Calibrate; Inappropriate Tactile Prompt/Feedback

  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 TOUCHSCREEN WAS OUT OF ALIGNMENT. THERE WAS NO REPORTED PATIENT INVOLVEMENT, THEREFORE NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21997505 ↗
• MalfunctionMay 7, 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 TOUCHSCREEN IS NOT WORKING PROPERLY. IT IS UNKNOWN IF THERE WAS A PATIENT INVOLVED AT THE TIME OF THE EVENT, HOWEVER NO HEALTH CONSEQUENCES OR IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21980794 ↗
• MalfunctionMay 4, 2025Break; Failure to Charge; Break; Failure to Charge

  IT HAS BEEN REPORTED TO PHILIPS, THAT DURING ROUTINE INSPECTION IT WAS NOTED THAT THE CHARGING PORT HAD BEEN DAMAGED. DUE TO DAMAGE THE TEMPUS PRO CAN NO LONGER BE CHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21957037 ↗
• MalfunctionApr 24, 2025Computer Software Problem; Computer Software Problem

  IT HAS BEEN REPORTED TO PHILIPS THAT CAN'T ENTER THE HOME SCREEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21898141 ↗
• MalfunctionApr 21, 2025Break; Charging Problem; Break; Charging Problem

  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 POWER SUPPLY CONNECTOR IS DAMAGED. IT IS UNKNOWN AT THIS TIME IF THE DEVICE WAS IN USE OR READY FOR USE AT THE TIME THE DAMAGE WAS DOCUMENTED. PATIENT IMPACT IS UNKNOWN AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21872343 ↗
• MalfunctionApr 18, 2025Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED TO PHILIPS THAT THE ECG MODULE FAILURE WAS NOTED DURING PERFORMANCE VERIFICATION. THE DEVICE WAS NOT IN CLINICAL USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21868018 ↗
• MalfunctionApr 17, 2025Power Problem; Power Problem

  IT WAS REPORTED TO PHILIPS THAT THE DEVICE IS NOT BOOTING UP CORRECTLY AND STAYS STUCK ON THE RDT LOGO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21859974 ↗
• MalfunctionApr 10, 2025Charging Problem; Charging 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 CHARGING PORT IS FAULTY. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE EVENT, THEREFORE NO PATIENT OR USER CONSEQUENCES OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21815892 ↗
• MalfunctionApr 6, 2025Erratic or Intermittent Display; Erratic or Intermittent Display

  IT HAS BEEN REPORTED TO PHILIPS THAT THE DEVICE TOUCH SCREEN APPEARS TO BE "OFFSET' BY 6MM AND THERE IS DELAY OF RESPONSE TO ANY TOUCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21782379 ↗
• MalfunctionApr 3, 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 NOT BOOTING UP PAST THE RDT LOGO SCREEN. IT IS UNKNOWN IF THERE WAS PATIENT IMPACT NOR INVOLVEMENT WAS NOTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21768411 ↗
• MalfunctionMar 28, 2025Unable to Obtain Readings; Failure of Device to Self-Test; Unable to Obtain Readings; Failure of Device to Self-Test

  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 CO2 LEAK TEST FAILED. THERE WAS NO REPORTED PATIENT INVOLVEMENT, THEREFORE NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21721590 ↗
• MalfunctionMar 24, 2025Inappropriate Tactile Prompt/Feedback; Inappropriate Tactile Prompt/Feedback

  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 TOUCHSCREEN APPEARS OFFSET BY 6MM ON THE BOTTOM RIGHT-HAND QUADRANT. THERE WAS NO REPORTED PATIENT INVOLVEMENT, THEREFORE NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21676186 ↗
• MalfunctionMar 21, 2025Installation-Related Problem; Installation-Related Problem

  IT WAS REPORTED TO PHILIPS THAT 12-LEAD ECG NOT ENABLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21665680 ↗
• MalfunctionMar 21, 2025Installation-Related Problem; Installation-Related Problem

  IT WAS REPORTED TO PHILIPS THAT THE FAST EXAM NOT ENABLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21665679 ↗
• MalfunctionMar 13, 2025Operating System Becomes Nonfunctional; Operating 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 STARTED UP WITH A USB (UNIVERSAL SERIAL BUS) DRIVER ERROR. THERE WAS NO REPORTED PATIENT INVOLVEMENT, THEREFORE NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21597409 ↗
• MalfunctionMar 5, 2025Wireless Communication Problem; Wireless Communication Problem

  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 WAS UNABLE TO CONNECT TO A TEMPUS LS MANUAL BY BLUETOOTH. THE DEVICE WAS NOT IN USE AT THE TIME OF THE PAIRING, NO IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21525839 ↗
• MalfunctionMar 3, 2025Break; Break

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY A FIELD SERVICE ENGINEER AND IS BEING INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THE ADAPTER FOR THE POWER CHARGER HAS A DAMAGED PIN. THIS ISSUE WAS DISCOVERED WHILE NOT IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21505475 ↗
• MalfunctionFeb 11, 2025Failure to Charge; Failure to Charge

  IT WAS REPORTED TO PHILIPS THAT THE POWER CONNECTOR BROKEN. NO PATIENT HARM OR INJURY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21353888 ↗
• MalfunctionFeb 6, 2025Charging Problem; Charging Problem

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY REMOTE SERVICE ENGINEER RSE AND WILL BE INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THE CENTRAL SHAFT OF THE POWER SUPPLY CONNECTOR IS BROKEN. NO HEALTH CONSEQUENCES OR IMPACT HAS BEEN INDICATED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21326636 ↗
• MalfunctionFeb 6, 2025Failure to Charge; Failure to Charge

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY THE REMOTE SERVICE ENGINEER RSE AND WILL BE INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THAT THE DEVICE CHARGE CIRCUIT WAS NOT FUNCTIONING. THE CUSTOMER TESTED WITH 3 DIFFERENT BATTERIES AND 3 DIFFERENT PSUS (POWER SUPPLY UNITS), BUT STILL THE BATTERY DOES NOT CHARGE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21321871 ↗