Remote Diagnostic Technologies Ltd.
FDA Regulatory Profile
Remote Diagnostic Technologies Ltd. has 12 FDA recalls, 3 inspections, 12 510(k) clearances and 0 compliance actions on record.
- Latest recall
- Z-1027-2026 · Class II · Nov 26, 2025
- Latest inspection
- May 31, 2024 · NAI
- Latest 510(k)
- Sep 18, 2020
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 12 | Oct 23, 2026 | Not stated | Current |
|---|
| 510(k) clearances | 12 | Oct 4, 2026 | Not stated | Current |
|---|
| Inspections | 3 | Oct 25, 2026 | Not stated | Current |
|---|
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1027-2026 | Class II | Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R… | Nov 26, 2025 |
| Z-2175-2025 | Class II | Inseego USB8 4G Dongle Kit, Part Number: 01-2298, which contains USB Flash Drive, Part Number… | May 30, 2025 |
| Z-1666-2025 | Class II | Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock)… | Apr 16, 2025 |
| Z-1729-2025 | Class II | Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004… | Apr 15, 2025 |
| Z-0557-2025 | Class III | Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can… | Oct 28, 2024 |
| Z-2028-2024 | Class II | Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual… | May 9, 2024 |
| Z-2625-2023 | Class II | Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, and… | Aug 24, 2023 |
| Z-1825-2023 | Class II | Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 | May 8, 2023 |
| Z-1321-2023 | Class II | Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and… | Feb 23, 2023 |
| Z-0861-2022 | Class II | Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693 | Jan 28, 2022 |
| Z-1997-2021 | Class II | Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm. Part No. - 00-1004-R… | May 25, 2021 |
| Z-0564-2021 | Class II | Tempus LS - Manual Defibrillator, Model Number: 00-3020 Software Version: 1.3.4 - Product Usage… | Nov 17, 2020 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| May 31, 2024 | Farnborough, United Kingdom | Devices | No Action Indicated (NAI) | 3003832357 |
| Jul 30, 2014 | Farnborough, United Kingdom | Devices | No Action Indicated (NAI) | 3003832357 |
| May 26, 2011 | Farnborough, United Kingdom | Devices | No Action Indicated (NAI) | 3003832357 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K201746 | Tempus Pro Patient Monitor | Sep 18, 2020 |
| K173768 | Tempus Pro Patient Monitor | Jan 10, 2018 |
| K170567 | Tempus Pro Patient Monitor | Jul 6, 2017 |
| K133973 | TEMPUS PRO WITH ENHANCED FEATURES | Aug 14, 2014 |
| K134014 | TEMPUS PRO ACCESSORIES (ULTRASOUND & VIDEO LARYNGOSCOPE PROBE) | Aug 12, 2014 |
| K133988 | TEMPUS PRO EXTENDED FEATURES | May 16, 2014 |
| K130773 | TEMPUS PRO PATIENT MONITOR | Jun 5, 2013 |
| K113105 | TEMPUSIC PATIENT MONITOR | Dec 15, 2011 |
| K101264 | TEMPUS IC PROFESSIONAL PATIENT MONITOR | May 11, 2010 |
| K082718 | TEMPUSIC PATIENT MONITOR | Oct 10, 2008 |
| K033410 | TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002 | Mar 5, 2004 |
| K010436 | TEMPUS 2000 PATIENT MONITOR, MODEL 00-0001; TEMPUS MONITORING STATION, MODEL 01-0011 | May 14, 2001 |