Reported May 14, 2025 · Ongoing
Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007
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 · N/A
Is this the product you have?
- Philips Tempus Pro Patient Monitor
- REF
00-1004-R00-1007-R00-1024-R00-1026-R00-100400-1007
- Lot codes and dates
6 of 6 products · 10 lot codes
Recalled lot codes, grouped by product number REF UDI-DI 00-1004-R0506047244002005060472442901
00-1007-R0506047244001305060472442918
00-1024-R0506047244102705060472442925
00-1026-R0506047244105805060472442932
00-100405060472440624
00-100705060472440655
- Amount recalled
- 6961
Where it was sold
Why it was recalled
Patient Monitor software update to address issues:1)May freeze at startup with MPM Application error and Attention Restart Required messages,2)Monitor may freeze and reboot at start of 12-lead ECG or after, 3)May reboot after intermittent connection with Smart Mount, 4) 12-lead ECG measurements with Louvain algorithm and software before vx.36 could produce inaccurate rhythm/morphology statements.
This product could cause temporary or reversible health problems — stop using it.
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