Reported Oct 2, 2024 · Ongoing

IntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 866061), MX450 (Model Number 866062), MX500…

Philips North America

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 · 222 Jacobs St · Cambridge, MA · 02141-2296

Is this the product you have?

  • IntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 866061), MX450 (Model Number 866062), MX500 (Model Number 866064), and MX550 (Model Number 866066)
Lot codes and dates

6 of 6 products

Products covered by this recall
#BarcodesProduct as published
10088483803875200884838038752
200884838057562IntelliVue Patient Monitor MX430, 866061, UDI-DI: 00884838057562
300884838038769IntelliVue Patient Monitor MX450, 866062, UDI-DI: 00884838038769
400884838038776IntelliVue Patient Monitor MX500, 866064, UDI-DI: 00884838038776
500884838038783IntelliVue Patient Monitor MX550, 866066, UDI-DI: 00884838038783
6Only MX400-550 devices shipped after 26-April-2024 are affected. Please refer to the manufacturing date on the back of your monitor.
Amount recalled
545 devices

Where it was sold

  • Nationwide

Why it was recalled

During a production process, Philips became aware of one IntelliVue power supply with a broken ground bolt upon disconnection of the ground cable from the equipotential ground connector. Loss of electrical grounding may negatively affect the devices electromagnetic immunity and emission.

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, 6:17 PM UTC

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