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Sources: EU EUDAMED, US FDA
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REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
FDA registration
REMOTE DIAGNOSTIC TECHNOLOGIES LTD.·19 products·🇬🇧 United Kingdom
TEMPUS PRO
FDA Adverse Event
Malfunction
·REMOTE DIAGNOSTIC TECHNOLOGIES LTD.·Product code MHX·January 6, 2023
TEMPUS PRO
FDA Adverse Event
Malfunction
·REMOTE DIAGNOSTIC TECHNOLOGIES LTD.·Product code MHX·January 6, 2023
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.
FDA Recall
Terminated
·Remote Diagnostic Technologies Ltd. The Old Coach House, The Av. Farleigh Wallop, Basingstoke Hampshire United Kingdom·Product code MWI·March 25, 2011
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)]
FDA Recall
Open, Classified
·Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom·Product code MHX·April 16, 2025
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
FDA Enforcement
Class II
·Ongoing·Remote Diagnostic Technologies Ltd.·January 14, 2026
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
FDA Enforcement
Class II
·Ongoing·Remote Diagnostic Technologies Ltd.·August 6, 2025
Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007
FDA Enforcement
Class II
·Ongoing·Remote Diagnostic Technologies Ltd.·May 14, 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
FDA Enforcement
Class III
·Ongoing·Remote Diagnostic Technologies Ltd.·December 4, 2024
Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693
FDA Enforcement
Class II
·Terminated·Remote Diagnostic Technologies Ltd.·April 13, 2022
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual
FDA Enforcement
Class II
·Ongoing·Remote Diagnostic Technologies Ltd.·June 12, 2024
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
FDA Enforcement
Class II
·Ongoing·Remote Diagnostic Technologies Ltd.·April 12, 2023
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).
FDA Enforcement
Class II
·Terminated·Remote Diagnostic Technologies Ltd.·December 23, 2020
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).
FDA Enforcement
Class II
·Ongoing·Remote Diagnostic Technologies Ltd.·July 7, 2021
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
FDA Enforcement
Class II
·Ongoing·Remote Diagnostic Technologies Ltd.·September 27, 2023
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020
FDA Enforcement
Class II
·Ongoing·Remote Diagnostic Technologies Ltd.·June 21, 2023
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)]
FDA Enforcement
Class II
·Ongoing·Remote Diagnostic Technologies Ltd.·April 30, 2025
TEMPUS PRO
FDA Adverse Event
Malfunction
·REMOTE DIAGNOSTIC TECHNOLOGIES LTD.·Product code MHX·October 27, 2021
TEMPUS PRO
FDA Adverse Event
Malfunction
·REMOTE DIAGNOSTIC TECHNOLOGIES LTD.·Product code MHX·September 5, 2024
TEMPUS PRO
FDA Adverse Event
Malfunction
·REMOTE DIAGNOSTIC TECHNOLOGIES LTD.·Product code MHX·August 29, 2024