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[Recalled] 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 — Full screen error message may occur on patient monitors with a

recall fda device united-kingdom

Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.

Recall details

ProductPhilips 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
Brand / manufacturerRemote Diagnostic Technologies Ltd.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-2625-2023
Country of noticeUnited Kingdom
Risk levelClass II
Hazard typerecall
Notice date24 August 2023
EAN / barcode05060472440020

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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.

This Class II recall concerns device products distributed in United Kingdom and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Remote Diagnostic Technologies Ltd.

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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