REMOTE DIAGNOSTIC TECHNOLOGIES LTD.

Recalls by year

Registered facilities (1)

• REMOTE DIAGNOSTIC TECHNOLOGIES LTD. FEI 3003832357 · GB

Recalls & enforcement

• Class IIOngoing2025-11-26
  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 clinic…
• Class IIOngoing2025-05-30
  Kit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated software and reintroducing the video laryngoscope issue (related to an August 2023 recall), which could lead to delay in diagnosis, delayed treatment, hypoxia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 unexpe…
• Class IIOngoing2025-04-16
  software issue that causes an error screen on a portable vital signs monitor when attaching video Laryngoscope.
• Class IIOngoing2025-04-15
  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 E…
• Class IIIOngoing2024-10-28
  Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number.
• Class IIOngoing2024-05-09
  Simultaneous ECG measurements with multiple devices, including a manual defibrillator, on the same patient may cause electrical noise or interference, which may lead to distortions of the ECG signal; distortions may lead to no or ineffective pacing, or no or inappropriate defibri…
• Class IIOngoing2023-08-24
  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…
• Class IIOngoing2023-05-08
  Defibrillator/pacemaker module (DPM) may encounter a problem causing communication from the Mainboard to the DPM to fail, leading to no or ineffective pacing with displayed error message "HW failure DPM".
• Class IIOngoing2023-02-23
  During internal testing, Regulatory Compliance issues were identified regarding the Monitor and Power Supplies for fluid ingress and basic safety issues.
• Class IITerminated2022-01-28
  Distribution of Defibrillators that are not approved or cleared for distribution US Market.
• Class IIOngoing2021-05-25
  The Tempus Pro (Trizeps 7 only) when used in combination with a specified laryngoscope device can cause two error types when subsequently unplugged.
• Class IITerminated2020-11-17
  A software error was detected within software version 1.3.4 for the Tempus LS device. When exiting pacer back into manual mode the pacer pulse wave may put the ECG calibration out of calibration. This software error may result in a delay in therapy, as the clinician is not provid…

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.