The Recall Desk
HighFDA (Devices)·Z-1729-2025·Announced 2025-05-14

[pending] Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-10

Pending LLM rewrite. Source: FDA_DEVICE Z-1729-2025.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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.

The recalled product

Product
Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007
Manufacturer
Remote Diagnostic Technologies Ltd.
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (10)

  • Software versions prior to vx.40. REF/UDI-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

Distribution

Distributed nationwide across the United States.

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