Remote Diagnostic Technologies Ltd.
FARNBOROUGH Hampshire, GB
REMOTE DIAGNOSTIC TECHNOLOGIES LTD. appears in FDA device records in FARNBOROUGH Hampshire, GB. FDA records list 12 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 13 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 12 510(k) clearances for Remote Diagnostic Technologies Ltd. between 2001 and 2020. The busiest year on record is 2014, with 3. The most recent is 2020, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 1 |
| 2004 | 1 |
| 2008 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2013 | 1 |
| 2014 | 3 |
| 2017 | 1 |
| 2018 | 1 |
| 2020 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K201746 | Tempus Pro Patient Monitor | MHX | Substantially Equivalent | |
| K173768 | Tempus Pro Patient Monitor | MHX | Substantially Equivalent | |
| K170567 | Tempus Pro Patient Monitor | MHX | Substantially Equivalent | |
| K133973 | TEMPUS PRO WITH ENHANCED FEATURES | QYW | Substantially Equivalent | |
| K134014 | TEMPUS PRO ACCESSORIES (ULTRASOUND & VIDEO LARYNGOSCOPE PROBE) | MWI | Substantially Equivalent | |
| K133988 | TEMPUS PRO EXTENDED FEATURES | MWI | Substantially Equivalent | |
| K130773 | TEMPUS PRO PATIENT MONITOR | MWI | Substantially Equivalent | |
| K113105 | TEMPUSIC PATIENT MONITOR | MWI | Substantially Equivalent | |
| K101264 | TEMPUS IC PROFESSIONAL PATIENT MONITOR | MWI | Substantially Equivalent | |
| K082718 | TEMPUSIC PATIENT MONITOR | DXH | Substantially Equivalent | |
| K033410 | TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002 | DXH | Substantially Equivalent | |
| K010436 | TEMPUS 2000 PATIENT MONITOR, MODEL 00-0001; TEMPUS MONITORING STATION, MODEL 01-0011 | DXH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003832357 | 3003832357 | REMOTE DIAGNOSTIC TECHNOLOGIES LTD. | ASCENT 1, FARNBOROUGH AEROSPACE CENTRE, FARNBOROUGH Hampshire GU14 6XW GB | 2026 | and 9 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LIXAid, Cardiopulmonary Resuscitation
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- DSKComputer, Blood-Pressure
- FLLContinuous Measurement Thermometer
- LDDDc-Defibrillator, Low-Energy, (Including Paddles)
- FFLDislodger, Stone, Basket, Ureteral, Metal
- DPSElectrocardiograph
- QYWHospital Cardiac Telemetry
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- DQAOximeter
- DROPacemaker, Cardiac, External Transcutaneous (Non-Invasive)
- DSBPlethysmograph, Impedance
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- ITXTransducer, Ultrasonic, Diagnostic
- DXHTransmitters And Receivers, Electrocardiograph, Telephone
- DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
- MNRVentilatory Effort Recorder
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1027-2026 | Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. USB 2-Channel IBP Module, REF: 01-2017. Used with User/Operator Manual | 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. | Class II | Open, Classified | |
| Z-2175-2025 | Inseego USB8 4G Dongle Kit, Part Number: 01-2298, which contains USB Flash Drive, Part Number: 43-2011. The kit is an accessory to the Tempus Pro Monitor, REF: 00-1007-R, 00-1024-R, 00-1026-R | 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. | Class II | Open, Classified | |
| Z-1666-2025 | Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007 (Tempus Pro non-printer, IBP, with headset dock), 00-1024-R (Tempus Pro printer), 00-1026-R (Tempus Pro printer, IBP), 00-1007 [(Tempus Pro, BT Dock (IB Only)], 00-1004 00-1004 [Tempus Pro (IB Only)] | software issue that causes an error screen on a portable vital signs monitor when attaching video Laryngoscope. | Class II | Open, Classified | |
| Z-1729-2025 | Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007 | 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. | Class II | Open, Classified | |
| Z-0557-2025 | Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock in manual or Pacemaker mode | Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number. | Class III | Open, Classified | |
| Z-2028-2024 | Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual | 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 defibrillation pulse. | Class II | Open, Classified | |
| Z-2625-2023 | Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, and 00-1007, when Used With Tempus Pro Video Laryngoscope, REF 01-2044 | 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. | Class II | Open, Classified | |
| Z-1825-2023 | Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 | 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 II | Open, Classified | |
| Z-1321-2023 | Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel, for the attended or unattended monitoring of single or multiple vital signs in clinical and pre hospital care applications. The affected power supplies are related to the following Tempus Pro Patient Monitoring units: Model Numbers: 00-1004 00-1004-R 00-1007 00-1007-R 00-1024-R 00-1026-R Model Numbers: 00-1004 00-1004-R 00-1007 00-1007-R 00-1024-R 00-1026-R | During internal testing, Regulatory Compliance issues were identified regarding the Monitor and Power Supplies for fluid ingress and basic safety issues. | Class II | Open, Classified | |
| Z-0861-2022 | Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693 | Distribution of Defibrillators that are not approved or cleared for distribution US Market. | Class II | Terminated | |
| Z-1997-2021 | Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm. Part No. - 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. Product Usage: intended to be used as a stand-alone monitor or as a telemedicine system (transmitting patient data to other medical professionals located elsewhere). | The Tempus Pro (Trizeps 7 only) when used in combination with a specified laryngoscope device can cause two error types when subsequently unplugged. | Class II | Open, Classified | |
| Z-0564-2021 | Tempus LS - Manual Defibrillator, Model Number: 00-3020 Software Version: 1.3.4 - Product Usage: The device is intended to be used in the following environmental: - Primarily in pre-hospital care and transport applications (including ambulances, fixed and rotary wing aircraft). | 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 provided an ECG waveform on which a shockable rhythm decision can be made. The device is still able to deliver a manual defibrillation shock. | Class II | Terminated | |
| Z-2183-2011 | TEMPUS IC PROFESSIONAL Patient Monitor, Part No. 00-1002, Manufactured by: Remote Diagnostics Technologies Ltd., The Old Coach House, Farleigh Wallop, Hants, UK RG25 2HT. Indicated for 3 Lead ECG monitoring and 12 Lead ECG recording, non-invasive blood pressure (NIBP), respiration, end-tidal C02 (ETCO 2), pulse oximetry (SP02) and tympanic temperature. | It was discovered that when a 12 Lead ECG is recorded and monitoring is quickly restarted, the ECG can cease functioning. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain