Farnborough, United Kingdom
Remote Diagnostic Technologies Ltd. recalls
12 recalls recorded since 2018, most recently on 26 November 2025. 10 are listed as ongoing. Status and classification are as published by the FDA.
Recalls12
Ongoing (FDA)10
Terminated or completed2
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 26 November 2025
- Reason
- Patient monitor measures Intracranial Pressure (ICP) and Bladder Pressure (BDR) but ICP and BDR measurements have not been tested or validated for accuracy. If healthcare providers base clinical judgment on unvalidated measurements, this could potentially lead to incorrect clinical decisions.
- Distribution
- Worldwide - US Nationwide distribution including in the states of AZ, VA, FL, CA, TX, NM, IA, NJ, TN, OH, KS, IN, NC, IL, WY, WI, NV, NY, NE, PA, AL, MA, GA, MO, CO, OK, KY, OR, MS, MI, HI, WA, UT, WV, ID, ND, NH, MN, MT, ME, MD, DE and the countries of AU, GB, IT, SA, DE, AE, BO, FR, ES, BE, IL, SG
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1027-2026
- 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
Ongoing Class II Medical devices
- Recall started
- 30 May 2025
- Reason
- Kit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated software and reintroducing the video laryngoscope issue (related to an August 2023 recall), which could lead to delay in diagnosis, delayed treatment, hypoxia due to unexpected loss of video laryngoscopy and all other monitor measurements during system restart.
- Distribution
- Worldwide - US Nationwide distribution in the states of SC, KY, NV, IA, MI and the country of GB.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2175-2025
- 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
Ongoing Class II Medical devices
- Recall started
- 16 April 2025
- Reason
- software issue that causes an error screen on a portable vital signs monitor when attaching video Laryngoscope.
- Distribution
- Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI, WV, WY and the countries of AE, AF, AT, AU, BE, BO, CA, CH, CZ, DE, DK, ES
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1666-2025
- 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
Ongoing Class II Medical devices
- Recall started
- 15 April 2025
- Reason
- Patient Monitor software update to address issues:1)May freeze at startup with MPM Application error and Attention Restart Required messages,2)Monitor may freeze and reboot at start of 12-lead ECG or after, 3)May reboot after intermittent connection with Smart Mount, 4) 12-lead ECG measurements with Louvain algorithm and software before vx.36 could produce inaccurate rhythm/morphology statements.
- Distribution
- Worldwide - US Nationwide distribution including in the states of AZ, VA, FL, CA, TX, NM, IA, NJ, TN, OH, KS, IN, NC, IL, WY, WI, NV, NY, NE, PA, AL, , MA, GA, MO, CO, OK, KY, OR, MS, MI, HI, WA, UT, WV, ID, ND, NH, MN, MT, ME, MD, DE, DC and the countries of AU, GB, IT, SA, DE, AE, BO, FR, ES, BE,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1729-2025
- Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007
Ongoing Class III Medical devices
- Recall started
- 28 October 2024
- Reason
- Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number.
- Distribution
- U.S. Nationwide distribution in the states of AL, CA, FL, MO, NY, OH, TX and VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0557-2025
- Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock in manual or Pacemaker mode
Ongoing Class II Medical devices
- Recall started
- 9 May 2024
- Reason
- Simultaneous ECG measurements with multiple devices, including a manual defibrillator, on the same patient may cause electrical noise or interference, which may lead to distortions of the ECG signal; distortions may lead to no or ineffective pacing, or no or inappropriate defibrillation pulse.
- Distribution
- US Nationwide distribution including in the states of VA, DC, MA, WY, AZ, FL, CA, NM, NJ, TN, OH, KS, IN, NY, IL, TX, NV, NE, PA, AL, IA, GA, MO, KY, WI, OR, CO, WV, WA, ET, UT, ID, OK, MN, ME, MT, MI, NC, ND, MD, DE, VT.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2028-2024
- Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual
Ongoing Class II Medical devices
- Recall started
- 24 August 2023
- Reason
- Full screen error message may occur on patient monitors with affected hardware version, either during or after laryngoscopes are unplugged from monitors, informing users a 60-100 second shutdown/restart are required. Error prevents: viewing graphical patient vital signs, sounding of pulse audio tone, visualization of patient airway used during intubation; may lead to treatment delay or hypoxia.
- Distribution
- US:AZ, AL, CA, CO, DC, DE, FL , GA, HI, IA, ID, IL, IN , KS, KY, MA , MD , ME, MI, MN, MO, MS, MT, NC , ND, NE, NJ, NM , NV, NY, OH, OK, OR, PA, TN, TX, UT, VA , WA, WI, WV, WY. OUS: AE, AT, AU, BE, BN, BO, CA, CH, CZ, DE, DK, ES, FR, GB, HK, IE, IL, IS, IT, KY, LU, MY, NL, NO, OM, PT, RO, SA, SE,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2625-2023
- 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
Ongoing Class II Medical devices
- Recall started
- 8 May 2023
- Reason
- Defibrillator/pacemaker module (DPM) may encounter a problem causing communication from the Mainboard to the DPM to fail, leading to no or ineffective pacing with displayed error message "HW failure DPM".
- Distribution
- US Nationwide distribution in the states of UT, CO, CA, NE, IL, TX, WV, KS, GA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1825-2023
- Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020
Ongoing Class II Medical devices
- Recall started
- 23 February 2023
- Reason
- During internal testing, Regulatory Compliance issues were identified regarding the Monitor and Power Supplies for fluid ingress and basic safety issues.
- Distribution
- Worldwide Distribution: U.S.(nationwide): AL, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI, WV, WY and O.U.S.(foreign): United Arab Emirates, Afghanistan, Austria, Australia, Belgium, Brunei
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1321-2023
- 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 an
Terminated Class II Medical devices
- Recall started
- 28 January 2022
- Terminated
- 25 July 2024
- Reason
- Distribution of Defibrillators that are not approved or cleared for distribution US Market.
- Distribution
- US Nationwide distribution in the states of IL and KS.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0861-2022
- Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693
Ongoing Class II Medical devices
- Recall started
- 25 May 2021
- Reason
- The Tempus Pro (Trizeps 7 only) when used in combination with a specified laryngoscope device can cause two error types when subsequently unplugged.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of FL, TX, PA, MN, UT, MT, CA, WI, VA, NY, TN, KS, MD and the countries of Australia, Austria, Czech Republic, France, Germany, Hong Kong, Israel, Italy, Netherlands, Thailand, Abu Dhabi, UK.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1997-2021
- 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
Terminated Class II Medical devices
- Recall started
- 17 November 2020
- Terminated
- 12 December 2023
- Reason
- A software error was detected within software version 1.3.4 for the Tempus LS device. When exiting pacer back into manual mode the pacer pulse wave may put the ECG calibration out of calibration. This software error may result in a delay in therapy, as the clinician is not provided an ECG waveform on which a shockable rhythm decision can be made. The device is still able to deliver a manual defibrillation shock.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0564-2021
- 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 applicati
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.