High FDA (Devices)·Z-1109-2025·Announced 2025-02-12

IntelliVue Patient Monitor MX500 may fail to generate critical alarms

Philips IntelliVue Patient Monitor MX500 units may fail to generate "No Device Data" alarms when a Hamilton ventilator disconnects, potentially delaying notification of loss of connectivity. 45 units distributed in the US and internationally.

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: FDA Class II device with a potential failure-to-alarm condition in a critical patient monitoring system. This represents a risk-of-harm to patients where injury has not yet been reported; the source explicitly describes a potential failure without documented illnesses or injuries.

Plain-English summary

Philips is recalling certain IntelliVue Patient Monitor MX500 units (Model 866064) due to a potential failure to generate alarms for "No Device Data" conditions. The device may fail to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board, which results in loss of device data communication.

This failure-to-alarm condition poses a patient safety risk because healthcare personnel may not be immediately notified when the monitor loses critical data transmission from connected ventilators, potentially delaying awareness of device disconnection or communication failures.

Approximately 45 units of the IntelliVue Patient Monitor MX500 were distributed in the United States (Florida, North Carolina, and Oregon) and internationally (Canada, Estonia, France, Germany, Japan, Netherlands, Spain, Switzerland, and United Kingdom). The device is identified by Model Number 866064.

Healthcare facilities that have received this device should contact Philips North America LLC for instructions regarding remediation or replacement. The FDA encourages healthcare providers to report any actual failures or adverse events related to this device.

The recalled product

Product: IntelliVue Patient Monitor MX500. Model Number: 866064
Manufacturer: Philips North America Llc
Category: Medical Device — Patient Monitoring
Hazard: failure-to-alarm
data-loss
Affected units: 45

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 (20)

Model Number: 866064. UDI-DI: (01)00884838038776(21)
Serial Numbers: DE7580A1R5
DE7580A1R4
DE7580A1R1
DE7580A1R0
DE7580A1PM
DE7580A1PL
DE7580A1PK
DE7580A1PJ
DE7580A1P5
DE351C8913
DE351C8912
DE351C8908
DE351C8911
DE351C8910
DE351C8909
DE32300881
DE32300882
DE32300883
DE32300937

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 5 recalled by Philips North America Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Same manufacturer · Philips North America Llc

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