Tempus Pro 00-1004-R (UDI 05060472440020)Recalls & reported problems
Remote Diagnostic Technologies Limited · Tempus Pro Rainbow - with Capnometry & without BT Dock · Class 2
All models of Tempus Pro (14)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
6 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Tempus Pro patient monitor is a portable vital signs monitor with capnometry. The 36 reports mostly describe the unit failing to power on, giving no readings, or breaking physically, including cracked rear covers, damaged ports, a dead keypad, a frozen or rebooting screen, and an unresponsive touchscreen;2 reports mention injuries and no deaths. Six recalls are open, covering unvalidated bladder and intracranial pressure readings plus software freezing, rebooting and error screens when a laryngoscope is plugged in. Reports dropped from 10 to 0 in the past 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 36
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 6
Summary
The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 05060472440020), received between Jun 17, 2021 and May 28, 2025 — classified as 2 injuries, 34 malfunctions.
The most frequently reported specific device problem is “Failure to Power Up” (5 reports).
6 FDA recall records name this device's identifier, 6 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Recalls naming this device
- 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 · Recall details · FDA record ↗
- 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 · Recall details · FDA record ↗
- 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 · Recall details · FDA record ↗
- 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 · Recall details · FDA record ↗
- 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 · Recall details · FDA record ↗
- 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 · Recall details · FDA record ↗
Most reported problems
Device problems
- Failure to Power Up5
- Break4
- Unable to Obtain Readings4
- Electrical /Electronic Property Problem3
- Charging Problem2
- Computer Operating System Problem2
- Computer Software Problem2
- Display or Visual Feedback Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions34
- Unspecified Heart Problem2
Recent adverse event reports
The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 28, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THAT THE DEFECTIVE LEFT KEYPAD FOUND DURING BENCH REPAIR. NO PATENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22097058 ↗MalfunctionMay 16, 2025Material Integrity Problem; Material Integrity Problem
PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THAT THE DEVICE REAR COVER WAS DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22034783 ↗MalfunctionMay 7, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THAT THE SBC EMERGENT FINDING AFTER REPLACING THE SYSTEM BOARD, THE DEVICE DIDN¿T REGISTER THE SD CARD. THE ISSUE WAS FOUND DURING BENCH REPAIR THEREFORE NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21975655 ↗MalfunctionMay 7, 2025Computer Software Problem; Computer Software Problem
PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THAT THE BOOT-LOOPING ISSUE WITH THE DEVICE OBSERVED DURING BENCH REPAIR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21975578 ↗MalfunctionMay 6, 2025No Tactile Prompts/Feedback; No Tactile Prompts/Feedback
HILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THE DEVICE DISPLAY WAS NOT RESPONDING TO TOUCH SCREEN. NO IMPACT TO PATIENT AS THIS ISSUE WAS DISCOVERED AT THE REPAIR BENCH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21966480 ↗MalfunctionApr 29, 2025Material Integrity Problem; Material Integrity Problem
PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THAT THE DEVICE REAR COVER WAS DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21928418 ↗MalfunctionApr 17, 2025Break; Charging Problem; Break; Charging Problem
IT WAS REPORTED TO PHILIPS THAT DAMAGE TO SOME OF THE PORTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21859392 ↗MalfunctionJan 29, 2025Electrical /Electronic Property Problem; Unable to Obtain Readings; Electrical /Electronic Property Problem; Unable to Obtain Readings
IT WAS REPORTED TO PHILIPS THAT THE ECG WAS DISABLED. NO PATIENT HARM OR INJURY HAS BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21263776 ↗MalfunctionDec 5, 2024Break; Break
IT WAS REPORTED TO PHILIPS THE DEVICE HAS A PHYSICALLY DAMAGED FRONT ENCLOSURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20857664 ↗MalfunctionNov 27, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT HAS BEEN REPORTED TO PHILIPS THAT THE DEVICE HAS AN UNRESPONSIVE SCREEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20801250 ↗MalfunctionOct 23, 2024Poor Quality Image; Poor Quality Image
IT HAS BEEN REPORTED TO PHILIPS THAT THE DISPLAY HAS A DARK PATCH ON THE SCREEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20514859 ↗MalfunctionOct 4, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO PHILIPS THAT ETCO2 PORT DUST COVER HAS BROKEN OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20371659 ↗InjurySep 26, 2024Unable to Obtain Readings; Operating System Becomes Nonfunctional; Unable to Obtain Readings; Operating System Becomes Nonfunctional
IT HAS BEEN REPORTED THAT THE DEVICE RECEIVED AN ERROR MESSAGE AND THEN LOCKED UP, RENDERING IT UNABLE TO OBTAIN PATIENT VITALS.
Patient problems: Unspecified Heart Problem
MAUDE report 20316641 ↗InjurySep 26, 2024Incorrect Measurement; Incorrect Measurement
IT HAS BEEN REPORTED THAT THE DEVICE INACCURATELY IDENTIFIED V-FIB MULTIPLE TIMES.
Patient problems: Unspecified Heart Problem
MAUDE report 20314989 ↗MalfunctionSep 26, 2024Failure to Calibrate; Failure to Calibrate
IT WAS REPORTED TO PHILIPS THAT DEVICE WON'T CALIBRATE. NO PATIENT HARM OR INJURY HAS BEEN REPORTED. FURTHER INFORMATION WILL BE SEND UPON COMPLETION OF THE MANUFACTURER'S INVESTIGATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20309531 ↗MalfunctionSep 17, 2024Charging Problem; Charging Problem
IT WAS REPORTED TO PHILIPS THAT CHARGING CONNECTOR IS LOOSE. NO PATIENT HARM OR INJURY HAS BEEN REPORTED. FURTHER INFORMATION WILL BE SEND UPON COMPLETION OF THE MANUFACTURER'S INVESTIGATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20236827 ↗MalfunctionSep 5, 2024Unable to Obtain Readings; Unable to Obtain Readings
IT WAS REPORTED THAT THE DEVICE INDICATES THE ECG CABLE IS NOT CONNECTED. IT IS UNKNOWN IF THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT, NO ADVERSE EVENT OR PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20148295 ↗MalfunctionAug 15, 2024Inappropriate Audible Prompt/Feedback; Inappropriate Audible Prompt/Feedback
IT HAS BEEN REPORTED THAT THE DEVICE HAS A STATIC NOISE BEING HERE FROM DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19996438 ↗MalfunctionJun 12, 2024Failure to Power Up; Failure to Power Up
IT HAS BEEN REPORTED TO PHILIPS THAT THERE IS ALSO A PROBLEM WITH IT BEING STUCK IN SELF-TEST MODE AND THEN WON'T SWITCH ON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19520954 ↗MalfunctionMay 17, 2024Failure to Power Up; Failure to Power Up
IT WAS REPORTED TO PHILIPS THAT THE DEVICE WILL NOT BOOT UP. NO PATIENT INVOLVEMENT OR HARM/INJURY HAS BEEN REPORTED. MORE INFORMATION WILL BE SEND UPON COMPLETED THEIR INVESTIGATION OF MANUFACTURERS INVESTIGATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19344294 ↗MalfunctionMay 13, 2024Break; Break
IT WAS REPORTED TO PHILIPS THAT THE DISPLAY WAS RESPONDING BUT HAD BAD SPOTS, TRIED SEVERAL SCREEN CALIBRATIONS AND NEW SCREEN FOIL BUT THAT DIDN'T SOLVE THE PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19303431 ↗MalfunctionMay 13, 2024Break; Break
IT WAS REPORTED TO PHILIPS THAT THE INTERNAL PART OF THE ETCO2 PORT IS DAMAGED SO ETCO2 MONITORING CAN'T BE CONNECTED. A USER REPORT WAS RECEIVED RELATED TO A REPORTED PRODUCT PROBLEM WHICH IS CURRENTLY BEING INVESTIGATED. FURTHER UPDATES WILL BE PROVIDED WHEN THE INVESTIGATION IS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19299363 ↗MalfunctionMar 26, 2024Unable to Obtain Readings; Unable to Obtain Readings
IT HAS BEEN REPORTED TO PHILIPS THE INSIDE OF THE ETCO2 PORT HAS BEEN DAMAGED WHEN A HOSPITAL STAFF MEMBER HAS PULLED OUT THE SENSOR CABLE, RATHER THAN UNSCREWING IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18980226 ↗MalfunctionMar 5, 2024No Pacing; No Pacing
IT HAS BEEN REPORTED TO PHILIPS THAT DURING THE RHYTHM ANALYSIS, THE DEFIBRILLATOR LOOPED AND REPEATEDLY ANNOUNCED: ""DO NOT TOUCH THE PATIENT, THE ANALYSIS IS IN PROGRESS..."" AT THE TOP OF THE SCREEN, IN AN ORANGE BOX, THE MESSAGE ""HARDWARE ERROR (DPM)"" PLUS A RED FLASHING LIGHT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18841950 ↗MalfunctionFeb 27, 2024Computer Operating System Problem; Computer Operating System Problem
IT HAS BEEN REPORTED TO PHILIPS THE DEVICE IS STUCK IN STARTUP SCREEN. IT STOPS BOOTING AT THE BLUE SCREEN WITH RDT SHOWING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18788795 ↗
Other Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) devices
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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