Remote Diagnostic Technologies Ltd.

FDA Regulatory Profile

Summary

Total Recalls
12
510(k) Clearances
11
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1027-2026Class IIPhilips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-November 26, 2025
Z-2175-2025Class IIInseego USB8 4G Dongle Kit, Part Number: 01-2298, which contains USB Flash Drive, Part Number: 43-20May 30, 2025
Z-1666-2025Class IITempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00April 16, 2025
Z-1729-2025Class IIPhilips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-10April 15, 2025
Z-0557-2025Class IIITempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deOctober 28, 2024
Z-2028-2024Class IIPhilips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/OperatMay 9, 2024
Z-2625-2023Class IIPhilips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, and 00August 24, 2023
Z-1825-2023Class IIPhilips Tempus LS-Manual Defibrillator, Part Number: 00-3020May 8, 2023
Z-1321-2023Class IITempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and mFebruary 23, 2023
Z-0861-2022Class IITempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693January 28, 2022
Z-1997-2021Class IITempus Pro - Patient physiological monitor, arrhythmia detector and alarm. Part No. - 00-1004-R, 0May 25, 2021
Z-0564-2021Class IITempus LS - Manual Defibrillator, Model Number: 00-3020 Software Version: 1.3.4 - Product Usage: ThNovember 17, 2020

Recent 510(k) Clearances

K-NumberDeviceDate
K173768Tempus Pro Patient MonitorJanuary 10, 2018
K170567Tempus Pro Patient MonitorJuly 6, 2017
K133973TEMPUS PRO WITH ENHANCED FEATURESAugust 14, 2014
K134014TEMPUS PRO ACCESSORIES (ULTRASOUND & VIDEO LARYNGOSCOPE PROBE)August 12, 2014
K133988TEMPUS PRO EXTENDED FEATURESMay 16, 2014
K130773TEMPUS PRO PATIENT MONITORJune 5, 2013
K113105TEMPUSIC PATIENT MONITORDecember 15, 2011
K101264TEMPUS IC PROFESSIONAL PATIENT MONITORMay 11, 2010
K082718TEMPUSIC PATIENT MONITOROctober 10, 2008
K033410TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002March 5, 2004
K010436TEMPUS 2000 PATIENT MONITOR, MODEL 00-0001; TEMPUS MONITORING STATION, MODEL 01-0011May 14, 2001