Remote Diagnostic Technologies Ltd.
FDA Regulatory Profile
Remote Diagnostic Technologies Ltd. appears in FDA public data with 12 recalls, 11 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1027-2026, Class II) was initiated on November 26, 2025. Its most recent 510(k) clearance was granted on January 10, 2018.
Summary
- Total Recalls
- 12
- 510(k) Clearances
- 11
- Inspections
- 3
- Compliance Actions
- 0
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, 00-1026- | November 26, 2025 |
| Z-2175-2025 | Class II | Inseego USB8 4G Dongle Kit, Part Number: 01-2298, which contains USB Flash Drive, Part Number: 43-20 | May 30, 2025 |
| Z-1666-2025 | Class II | Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00 | April 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, 00-10 | April 15, 2025 |
| Z-0557-2025 | Class III | Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can de | October 28, 2024 |
| Z-2028-2024 | Class II | Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operat | 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 00 | August 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 m | February 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 | January 28, 2022 |
| Z-1997-2021 | Class II | Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm. Part No. - 00-1004-R, 0 | May 25, 2021 |
| Z-0564-2021 | Class II | Tempus LS - Manual Defibrillator, Model Number: 00-3020 Software Version: 1.3.4 - Product Usage: Th | November 17, 2020 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K173768 | Tempus Pro Patient Monitor | January 10, 2018 |
| K170567 | Tempus Pro Patient Monitor | July 6, 2017 |
| K133973 | TEMPUS PRO WITH ENHANCED FEATURES | August 14, 2014 |
| K134014 | TEMPUS PRO ACCESSORIES (ULTRASOUND & VIDEO LARYNGOSCOPE PROBE) | August 12, 2014 |
| K133988 | TEMPUS PRO EXTENDED FEATURES | May 16, 2014 |
| K130773 | TEMPUS PRO PATIENT MONITOR | June 5, 2013 |
| K113105 | TEMPUSIC PATIENT MONITOR | December 15, 2011 |
| K101264 | TEMPUS IC PROFESSIONAL PATIENT MONITOR | May 11, 2010 |
| K082718 | TEMPUSIC PATIENT MONITOR | October 10, 2008 |
| K033410 | TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002 | March 5, 2004 |
| K010436 | TEMPUS 2000 PATIENT MONITOR, MODEL 00-0001; TEMPUS MONITORING STATION, MODEL 01-0011 | May 14, 2001 |