Reported Feb 12, 2025 · Ongoing

IntelliVue Patient Monitor MX400. Model Number: 866060

Philips North America LLC

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: Philips North America Llc · 222 Jacobs St · Cambridge, MA · 02141-2289

Is this the product you have?

  • IntelliVue Patient Monitor MX400
  • Model Number866060
Lot codes and dates
  • Model Number866060
  • UDI-DI Number(01)00884838038752(21)
  • Serial Numbers
    • DE35174105
    • DE35174084
    • DE35174083
    • DE35174082
    • DE35174080
    • DE35107369
    • DE35108320
    • DE35160410
    • DE671M4116
    • DE7770DA9W
    • DE35114616
    • DE35114618
    • DE671E8921
    • DE671E8917
    • DE7580AH50
    • DE7580AHEH
    • DE35123130
    • DE671V9297
    • DE671V9296
    • DE671V9298
    • DE35160989
    • DE35160994
    • DE35160988
    • DE35161272
    • DE35161273
    • DE35161274
    • DE7580B537
    • DE7580B52H
Amount recalled
28 units

This recall covers 5 products

The agency filed one notice per product. You are reading one of them; the other 4 are below.

Where it was sold

Why it was recalled

Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.

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, 5:37 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.