Tempus Pro 00-1007Recalls & reported problems
Remote Diagnostic Technologies Limited · Class 2
All models of Tempus Pro (14)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
4 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 4
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05060472440655), received between Jun 29, 2023 and Aug 26, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Power Up” (1 report).
4 FDA recall records name this device's identifier, 4 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.
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 ↗
Most reported problems
Device problems
- Failure to Power Up1
- Operating System Becomes Nonfunctional1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 26, 2023Failure to Power Up; Failure to Power Up
IT WAS REPORTED THAT, WHEN THE NURSE USED THE DEFIBRILLATOR/MONITOR FOR ROUTINE TESTING, THE DEVICE WAS FOUND TO ALARM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17628869 ↗MalfunctionJun 29, 2023Operating System Becomes Nonfunctional; Operating System Becomes Nonfunctional
IT HAS BEEN REPORTED TO PHILIPS THAT AFTER SOFTWARE UPDATE, AN CRC ERROR WITH ONE OR MORE CONFIGURATION FILES OCCURRED. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17232638 ↗
Other Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) devices
- IntelliVue MX40 1.4GHz MX40 1.4 GHz Smart HoppingPhilips Medical Systems Hsg · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 recall47 deaths2,541 reports
- NA PU-621RNihon Kohden Corporation · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)17 deaths1,666 reports
- Tempus Pro 00-1024-RRemote Diagnostic Technologies Limited · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)7 recalls8 deaths1,217 reports
- NA PU-681RANihon Kohden Corporation · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)22 deaths1,493 reports
- IntelliVue Multi-Measurement Module X3 IntelliVue X3Philips Medizin Systeme Böblingen GmbH · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 recall19 deaths1,172 reports
- Patient Information Center IXPhilips Medical Systems Hsg · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)82 deaths941 reports
- Patient Information Center iXPhilips Medical Systems Hsg · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)83 deaths814 reports
- Tempus Pro 00-1024-RRemote Diagnostic Technologies Limited · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)5 recalls541 reports
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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