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Tempus Pro 00-1004Recalls & reported problems

Remote Diagnostic Technologies Limited · Class 2

4 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
4

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

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. 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. 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 ↗

  3. 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 ↗

  4. 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 ↗

Other Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) devices

All Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.