FDA recall record · openFDA

Remote Diagnostic Technologies Ltd.

9 FDA recalls on record (2023–2025) — 9 device. 9 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Patient Monitor software update to address issues:1)May freeze at startup with MPM Application error and Attention Resta 1

During internal testing, Regulatory Compliance issues were identified regarding the Monitor and Power Supplies for fluid 1

Defibrillator/pacemaker module (DPM) may encounter a problem causing communication from the Mainboard to the DPM to fai 1

Full screen error message may occur on patient monitors with affected hardware version, either during or after laryngosc 1

Patient monitor measures Intracranial Pressure (ICP) and Bladder Pressure (BDR) but ICP and BDR measurements have not be 1

Recalls

Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007 Class II 2025-04-15 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 Class II 2025-11-26 Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007 Class II 2025-04-16 Inseego USB8 4G Dongle Kit, Part Number: 01-2298, which contains USB Flash Drive, Part Number: 43-2011. The kit is an ac Class II 2025-05-30 Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual Class II 2024-05-09 Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified p Class II 2023-02-23 Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 Class II 2023-05-08 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 Wit Class II 2023-08-24 Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock in man Class III 2024-10-28

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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