Reported Apr 12, 2023 · Ongoing

Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified…

Remote Diagnostic Technologies Ltd.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Remote Diagnostic Technologies Ltd. · Farnborough Aerospace Centre · Farnborough · N/A

Is this the product you have?

  • 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 hospital care applications. The affected power supplies are related to the following
  • Tempus Pro Patient Monitoring unitsModel
  • Numbers00-1004 00-1004-R 00-1007 00-1007-R 00-1024-R 00-1026-R
  • Model Numbers00-1004 00-1004-R 00-1007 00-1007-R 00-1024-R 00-1026-R
Lot codes and dates

4 of 4 products

Products covered by this recall
Model / numberBarcodesProduct as published
050604724400200506047244290100-1007 00-1007-R UDI-DI Codes
050604724400130506047244290100-1024-R UDI-DI Codes
050604724410270506047244292500-1026-R UDI-DI Codes
0506047244105805060472442932Lot Codes - All products manufactured are affected.
Amount recalled
5,540 units

Where it was sold

Why it was recalled

During internal testing, Regulatory Compliance issues were identified regarding the Monitor and Power Supplies for fluid ingress and basic safety issues.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:22 PM UTC

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