The Recall Desk
HighFDA (Devices)·Z-0862-2026·Announced 2025-12-10

[pending] IntelliVue Patient Monitor MX400. Product Number: 866060.

Pending LLM rewrite. Source: FDA_DEVICE Z-0862-2026.

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

Potential issue where the IntelliVue monitors did not alarm.

The recalled product

Product
IntelliVue Patient Monitor MX400. Product Number: 866060.
Manufacturer
Philips North America Llc

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 (3)

  • Product Number: 866060
  • UDI-DI: 00884838038752
  • All Serial No.

Distribution

Distributed nationwide across the United States.