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Remote Diagnostic Technologies Ltd. FDA Recalls

11 recalls on file across devices, 0 of them Class I and 10 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product
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 IINov 26, 2025Patient monitor measures Intracranial Pressure (ICP) and Bla
Inseego USB8 4G Dongle Kit, Part Number: 01-2298, which contains USB Flash Drive, Part Number: 43-2011. The kit is an acClass IIMay 30, 2025Kit USB flash drive contains outdated software, which could
Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007 Class IIApr 16, 2025software issue that causes an error screen on a portable vit
Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007Class IIApr 15, 2025Patient Monitor software update to address issues:1)May free
Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock in manClass IIIOct 28, 2024Due to incorrect labels applied to devices during servicing.
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator ManualClass IIMay 9, 2024Simultaneous ECG measurements with multiple devices, includi
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 WitClass IIAug 24, 2023Full screen error message may occur on patient monitors with
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020Class IIMay 8, 2023Defibrillator/pacemaker module (DPM) may encounter a problem
Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified pClass IIFeb 23, 2023During internal testing, Regulatory Compliance issues were i
Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693Class IIJan 28, 2022Distribution of Defibrillators that are not approved or cle
Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm. Part No. - 00-1004-R, 00-1007-R, 00-1024-R,Class IIMay 25, 2021The Tempus Pro (Trizeps 7 only) when used in combination wit

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