Reported Sep 27, 2023 · Ongoing

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…

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-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
Lot codes and dates

6 of 6 products · 10 lot codes

Recalled lot codes, grouped by product number
REFUDI-DI
00-1004-R
  • 05060472440020
  • 05060472442901
00-1007-R
  • 05060472440013
  • 05060472442918
00-1024-R
  • 05060472441027
  • 05060472442925
00-1026-R
  • 05060472441058
  • 05060472442932
00-1004
  • 05060472440624
00-1007
  • 05060472440655
Amount recalled
3,524

Where it was sold

Why it was recalled

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 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, 6:21 PM UTC

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