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Tempus ProRecalls & reported problems across all models

Remote Diagnostic Technologies Limited · 14 models in the FDA device registry

Data updated Oct 16, 2026 from official FDA records · Editorial policy

7 open recalls name at least one Tempus Pro model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.

Adverse event reports
2,558
Deaths reported
9
Injuries reported
22
Recalls
7

We found 14 models of Tempus Pro by Remote Diagnostic Technologies Limited in the FDA's device registry (GUDID). Together they are named in 2,558 adverse event reports in the FDA's MAUDE database, received between Jun 17, 2021 and Sep 30, 2026 — classified as 9 deaths, 22 injuries, 2,527 malfunctions.

The most frequently reported specific device problem is “Unable to Obtain Readings” (413 reports).

7 FDA recall records name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Reports received per month, all models

Nov 2023: 36 reportsDec 2023: 66 reportsJan 2024: 54 reportsFeb 2024: 75 reportsMar 2024: 93 reportsApr 2024: 60 reportsMay 2024: 53 reportsJun 2024: 66 reportsJul 2024: 47 reportsAug 2024: 50 reportsSep 2024: 45 reportsOct 2024: 53 reportsNov 2024: 48 reportsDec 2024: 30 reportsJan 2025: 69 reportsFeb 2025: 60 reportsMar 2025: 77 reportsApr 2025: 77 reportsMay 2025: 56 reportsJun 2025: 72 reportsJul 2025: 81 reportsAug 2025: 40 reportsSep 2025: 41 reportsOct 2025: 98 reportsNov 2025: 47 reportsDec 2025: 62 reportsJan 2026: 58 reportsFeb 2026: 59 reportsMar 2026: 64 reportsApr 2026: 34 reportsMay 2026: 60 reportsJun 2026: 41 reportsJul 2026: 47 reportsAug 2026: 46 reportsSep 2026: 58 reportsOct 2026: 0 reports20242025202698
Last 36 months. The most recent month may be incomplete.

Tempus Pro recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

  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 · names 10 of these models · Recall details · 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 · names 6 of these models · Recall details · 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 · names 10 of these models · Recall details · 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 · names 10 of these models · Recall details · 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 · names 10 of these models · Recall details · 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 · names 4 of these models · Recall details · 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 · names 4 of these models · Recall details · FDA record ↗

Most reported Tempus Pro problems

Device problems

  • Unable to Obtain Readings413
  • Failure to Charge238
  • Display or Visual Feedback Problem220
  • Break214
  • Erratic or Intermittent Display194
  • Charging Problem175
  • Operating System Becomes Nonfunctional127
  • Unexpected Shutdown126

Patient problems

  • No Clinical Signs, Symptoms or Conditions2,502
  • Cardiac Arrest40
  • Insufficient Information34
  • Unspecified Heart Problem29
  • Chest Pain5
  • Bradycardia3
  • Asystole2
  • Hemodynamic instability2

Tempus Pro models

14 models, most reported first. Each model has its own page with its reports, recalls and device details.

Recent Tempus Pro adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page