CLASS II ONGOING Device recall · Reported 2 Oct 2024 · FDA Enforcement Report

IntelliVue Patient Monitor MX400 recalled by Philips North America

Philips North America is recalling IntelliVue Patient Monitor MX400 (, distributed nationwide in the US. The recall was initiated on 30 Aug 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesIntelliVue Patient Monitor MX400, 866060, UDI-DI: 00884838038752; IntelliVue Patient Monitor MX430, 866061, UDI-DI: 00884838057562; IntelliVue Patient Monitor MX450, 866062, UDI-DI: 00884838038769; IntelliVue Patient Monitor MX500, 866064, UDI-DI: 00884838038776; IntelliVue Patient Monitor MX550, 866066, UDI-DI: 00884838038783; Only MX400-550 devices shipped after 26-April-2024 are affected. Please refer to the manufacturing date on the back of your monitor.

Quantity recalled545 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-3249-2024
FDA event ID: 95295
Recalling firm: Philips North America, Cambridge, MA
Classification: Class II
Status: Ongoing
Recall initiated: 30 Aug 2024
FDA classified: 25 Sep 2024
Reported: 2 Oct 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Patient Monitors

Timeline

30 Aug 2024	Recall initiated by company
25 Sep 2024	Classified by FDA	+26 days
2 Oct 2024	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

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

Where it was distributed

US Nationwide. Global Distribution.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

IntelliVue Patient Monitor MX400, 866060, UDI-DI: 00884838038752; IntelliVue Patient Monitor MX430, 866061, UDI-DI: 00884838057562; IntelliVue Patient Monitor MX450, 866062, UDI-DI: 00884838038769; IntelliVue Patient Monitor MX500, 866064, UDI-DI: 00884838038776; IntelliVue Patient Monitor MX550, 866066, UDI-DI: 00884838038783; Only MX400-550 devices shipped after 26-April-2024 are affected. Please refer to the manufacturing date on the back of your monitor.

Where was it sold?

US Nationwide. Global Distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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