Reported Jan 14, 2026 · Ongoing

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…

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?

  • 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 IBP Module
  • REF01-2017. Used with User/Operator Manual
Lot codes and dates

6 of 6 products · 10 lot codes

Recalled lot codes, grouped by product number
REFUDI-DI
00-1004
  • 05060472440624
00-1007
  • 05060472440655
00-1004-R
  • 05060472440020
  • 05060472442901
00-1007-R
  • 05060472440013
  • 05060472442918
00-1024-R
  • 05060472441027
  • 05060472442925
00-1026-R
  • 05060472441058
  • 05060472442932
Amount recalled
7129

Where it was sold

Why it was recalled

Patient monitor measures Intracranial Pressure (ICP) and Bladder Pressure (BDR) but ICP and BDR measurements have not been tested or validated for accuracy. If healthcare providers base clinical judgment on unvalidated measurements, this could potentially lead to incorrect clinical decisions.

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, 4:15 PM UTC

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