Tempus IC2 00-2001-RRecalls & reported problems
Remote Diagnostic Technologies Limited · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Philips Tempus IC2 is a portable patient monitor used to track vital signs. The 32 reports mostly describe the unit failing to start up or freezing on its startup screen, plus display problems and difficulty getting readings. No deaths and no injuries are reported, and most reports say no patient was involved. No recalls name this device.
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
- 32
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 05060472440488), received between Mar 23, 2023 and Jul 28, 2026 — classified as 32 malfunctions.
The most frequently reported specific device problem is “Failure to Power Up” (7 reports).
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.
Reports received per month
Most reported problems
Device problems
- Failure to Power Up7
- Display or Visual Feedback Problem4
- Communication or Transmission Problem3
- Unable to Obtain Readings3
- No Device Output2
- No Tactile Prompts/Feedback2
- Operating System Becomes Nonfunctional2
- Application Program Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions29
- Insufficient Information2
- Unspecified Heart Problem1
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 28, 2026Fitting Problem; Incomplete or Inadequate Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50057529 ↗MalfunctionJul 10, 2025Application Program Problem; Application Program 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 WILL NOT PASS BOOT PHASE AND PRESENTED WITH THE RDT PHILIPS START-UP SCREEN/LOADING SCREEN AND THEN THE DEVICE DOES NOT PROGRESS ANY FURTHER. THE DEVICE WAS NOT IN USE AT THE TIME OF THE EVENT IS UNKNOWN AND NO IMPACT TO PATIENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22468388 ↗MalfunctionApr 18, 2025Operating System Version or Upgrade Problem; Operating System Version or Upgrade Problem
THIS REPORT IS BASED ON INFORMATION PROVIDED BY A PHILIPS REMOTE SERVICE ENGINEER AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS IC2 INDICATING WHEN INSTALLING SOFTWARE UPGRADE, THE DEVICE DID NOT LOAD THE WAY THE ATTACHED GUIDE SAID IT WOULD. THERE WAS NO PATIENT INVOLVEMENT REPORTED, THEREFORE NO HEALTH CONSEQUENCES OR IMPACT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21867859 ↗MalfunctionDec 18, 2024No Tactile Prompts/Feedback; No Tactile Prompts/Feedback
IT HAS BEEN REPORTED TO PHILIPS THE DEVICE SCREEN IS UNRESPONSIVE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20966643 ↗MalfunctionDec 6, 2024Display or Visual Feedback Problem; Failure to Power Up; Display or Visual Feedback Problem; Failure to Power Up
IT HAS BEEN REPORTED TO PHILIPS THAT THE DEVICE IS NOT POWERING ON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20869753 ↗MalfunctionDec 5, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED TO PHILIPS THAT THE TEMPUS PRO CANNOT USE, WILL NOT MOVE BEYOND THE RDT 'A PHILIPS COMPANY' SCREEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20851658 ↗MalfunctionDec 5, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT HAS BEEN REPORTED TO PHILIPS THAT THE FROZEN SCREEN: BLUE SCREEN RDT "A PHILIPS COMPANY" CANNOT MOVE FORWARD DESPITE TURNING ON/OFF OR PRESSING OTHER BUTTONS ON THE UNIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20851657 ↗MalfunctionOct 2, 2024Failure to Power Up; Power Problem; Failure to Power Up; Power Problem
IT WAS REPORTED TO PHILIPS THAT INTERMITTENT POWER FAILURE, STUCK IN THE BOOT PHASE WITH GREEN LED FLASHING. NOT IN CLINICAL USE AND NO PATIENT OR USER HARM. ISSUE FOUND DURING ROUTINE INSPECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20353056 ↗MalfunctionOct 2, 2024Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED TO PHILIPS THAT TEMPUS FAILING CONNECTIVITY ON AIRCRAFT. NOT IN CLINICAL USE AND NO PATIENT OR USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20350166 ↗MalfunctionSep 12, 2024Failure to Power Up; Failure to Power Up
IT HAS BEEN REPORTED TO PHILIPS THAT THE TEMPUS IC2 DEVICE IS NOT SWITCHING ON. THE DEVICE WAS NOT IN CLINICAL USE AND NO PATIENT OR USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20203117 ↗MalfunctionJul 1, 2024Unable to Obtain Readings; Unable to Obtain Readings
IT HAS BEEN REPORTED THAT THE DEVICE IS NOT READING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19651898 ↗MalfunctionJun 3, 2024Display or Visual Feedback Problem; Failure to Power Up; Display or Visual Feedback Problem; Failure to Power Up
IT WAS REPORTED TO PHILIPS THAT THE SCREEN IS NOT RESPONDING. 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 19446491 ↗MalfunctionMay 23, 2024Failure to Power Up; Failure to Power Up
IT HAS BEEN REPORTED TO PHILIPS THE DEVICE DOES NOT BOOT. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19383615 ↗MalfunctionMay 20, 2024No Tactile Prompts/Feedback; No Tactile Prompts/Feedback
IT HAS BEEN REPORTED TO PHILIPS THAT THE SCREEN IS UNRESPONSIVE. THE DEVICE WAS NOT IN CLINICAL USE AND NO PATIENT OR USER HARM. 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 19353240 ↗MalfunctionMar 26, 2024Charging Problem; Charging Problem
PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS IC2. WHEN THE ISSUE WAS INVESTIGATED AT THE BENCH IT WAS OBSERVED THAT THE DC(DIRECT CURRENT) CONNECTOR IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18980425 ↗MalfunctionMar 13, 2024Operating System Becomes Nonfunctional; Operating System Becomes Nonfunctional
IT HAS BEEN REPORTED TO PHILIPS THE DEVICE ISN¿T BOOTING PAST THE PERFORMING SELF-TEST SCREEN. THE CUSTOMER HAS TRIED MULTIPLE TIMES WITH THE SAME OUTCOME. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18895331 ↗MalfunctionMar 11, 2024No Device Output; No Device Output
IT WAS REPORTED TO PHILIPS THAT ECG WAS NOT WORKING. 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 18874841 ↗MalfunctionFeb 21, 2024No Display/Image; No Display/Image
IT WAS REPORTED TO PHILIPS THAT THE WHEN TURNED ONLY BLUE SCREEN APPEARS AND NO BUTTONS WORK. 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 18747648 ↗MalfunctionFeb 19, 2024Computer Software Problem; Computer Software Problem
IT HAS BEEN REPORTED TO PHILIPSWE HAVE A TEMPUS IC2 THAT WAS FULLY CHARGED BUT WOULDN¿T BOOT UP ¿ IT WOULD POWER ON AND HANG ON THE RDT SPLASH SCREEN. WE TRIED RESTARTING SEVERAL TIMES WHICH PRODUCED THE SAME RESULT. NEXT, WE LEFT IT PLUGGED IN TO POWER OVERNIGHT AND IT BOOTED NORMALLY THE FOLLOWING MORNING. AFTER REPEATEDLY POWER CYCLING THE UNIT TO TEST, WE ARE FINDING THAT THE TEMPUS IS INTERMITTENTLY EXHIBITING THE SAME BOOT UP ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18735405 ↗MalfunctionAug 31, 2023Break; Break
IT HAS BEEN REPORTED THAT THE DEVICE'S PULSE OXYMETER PINS ARE BROKEN. PATIENT INVOLVEMENT IS UNCONFIRMED.
Patient problems: Insufficient Information
MAUDE report 17666997 ↗MalfunctionAug 31, 2023Unable to Obtain Readings; Unable to Obtain Readings
IT HAS BEEN REPORTED THAT THE DEVICE HAS NO CONNECTION TO MEDLINK AND NO ECG READING. PATIENT INVOLVEMENT IS UNCONFIRMED.
Patient problems: Unspecified Heart Problem
MAUDE report 17666431 ↗MalfunctionJun 22, 2023Intermittent Loss of Power; Intermittent Loss of Power
IT HAS BEEN REPORTED TO PHILIPS THE UNIT WAS POWERING ON AND OFF ON ITS OWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17186012 ↗MalfunctionJun 8, 2023Failure of Device to Self-Test; Failure of Device to Self-Test
IT HAS BEEN REPORTED TO PHILIPS THAT THE DEVICE GETS STUCK IN SELF-TEST MODE UPON POWERING ON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17091690 ↗MalfunctionApr 20, 2023Failure to Power Up; Failure to Power Up
IT HAS BEEN REPORTED TO PHILIPS THAT "UNIT DOES NOT BOOT". 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 16775308 ↗MalfunctionApr 6, 2023Failure to Analyze Signal; Failure to Analyze Signal
IT HAS BEEN REPORTED TO PHILIPS THE DEVICE A FAULTY ECG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16688786 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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