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[Recalled] 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 and pre hos

recall fda device united-kingdom

Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.

Recall details

ProductTempus 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 and pre hospital care applications. The affected power supplies are related to
Brand / manufacturerRemote Diagnostic Technologies Ltd.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-1321-2023
Country of noticeUnited Kingdom
Risk levelClass II
Hazard typerecall
Notice date23 February 2023
EAN / barcode05060472440020

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: During internal testing, Regulatory Compliance issues were identified regarding the Monitor and Power Supplies for fluid ingress and basic safety issues.

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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