Remote Diagnostic Technologies Ltd.
Medical device manufacturer in Farnborough, Unit.
12510(k) clearances
0PMA approvals
13recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K201746 | Tempus Pro Patient MonitorMHX · Special | 09/18/2020SE |
| K173768 | Tempus Pro Patient MonitorMHX · Special | 01/10/2018SE |
| K170567 | Tempus Pro Patient MonitorMHX · Traditional | 07/06/2017SE |
| K133973 | Tempus Pro with Enhanced FeaturesQYW · Abbreviated | 08/14/2014SE |
| K134014 | Tempus Pro Accessories (Ultrasound & Video Laryngoscope Probe)MWI · Traditional | 08/12/2014SE |
| K133988 | Tempus Pro Extended FeaturesMWI · Abbreviated | 05/16/2014SE |
| K130773 | Tempus Pro Patient MonitorMWI · Traditional | 06/05/2013SE |
| K113105 | Tempusic Patient MonitorMWI · Abbreviated | 12/15/2011SE |
| K101264 | Tempus Ic Professional Patient MonitorMWI · Traditional | 05/11/2010SE |
| K082718 | Tempusic Patient MonitorDXH · Traditional | 10/10/2008SE |
| K033410 | Tempus 2000 Patient Monitor, Model 00-0002DXH · Traditional | 03/05/2004SE |
| K010436 | Tempus 2000 Patient Monitor, Model 00-0001; Tempus Monitoring Station, Model 01-0011DXH · Traditional | 05/14/2001SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1027-2026 Class II | Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R…Patient monitor measures Intracranial Pressure (ICP) and Bladder Pressure (BDR) but ICP and BDR measurements… | 11/26/2025Open, Classified |
| Z-2175-2025 Class II | Inseego USB8 4G Dongle Kit, Part Number: 01-2298, which contains USB Flash Drive, Part…Kit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated… | 05/30/2025Open, Classified |
| Z-1666-2025 Class II | Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without…software issue that causes an error screen on a portable vital signs monitor when attaching video… | 04/16/2025Open, Classified |
| Z-1729-2025 Class II | Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R…Patient Monitor software update to address issues:1)May freeze at startup with MPM Application error and… | 04/15/2025Open, Classified |
| Z-0557-2025 Class III | Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator…Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and… | 10/28/2024Open, Classified |
| Z-2028-2024 Class II | Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual…Simultaneous ECG measurements with multiple devices, including a manual defibrillator, on the same patient… | 05/09/2024Open, Classified |
| Z-2625-2023 Class II | Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R…Full screen error message may occur on patient monitors with affected hardware version, either during or… | 08/24/2023Open, Classified |
| Z-1825-2023 Class II | Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020Defibrillator/pacemaker module (DPM) may encounter a problem causing communication from the Mainboard to the… | 05/08/2023Open, Classified |
| Z-1321-2023 Class II | Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by…During internal testing, Regulatory Compliance issues were identified regarding the Monitor and Power… | 02/23/2023Open, Classified |
| Z-0861-2022 Class II | Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI:…Distribution of Defibrillators that are not approved or cleared for distribution US Market. | 01/28/2022Terminated |
| Z-1997-2021 Class II | Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm. Part No. -…The Tempus Pro (Trizeps 7 only) when used in combination with a specified laryngoscope device can cause two… | 05/25/2021Open, Classified |
| Z-0564-2021 Class II | Tempus LS - Manual Defibrillator, Model Number: 00-3020 Software Version: 1.3.4 -…A software error was detected within software version 1.3.4 for the Tempus LS device. When exiting pacer… | 11/17/2020Terminated |
| Z-2183-2011 | TEMPUS IC PROFESSIONAL Patient Monitor, Part No. 00-1002, Manufactured by: Remote…It was discovered that when a 12 Lead ECG is recorded and monitoring is quickly restarted, the ECG can cease… | 03/25/2011Terminated |