Class II

Medical Device Recall: IntelliVue Patient Monitor MX450. Model Number: 866062

Philips North America Llc · January 15, 2025

Reason for Recall

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.

Distribution

US distribution to Florida, North Carolina, and Oregan. International distribution to Canada, Estonia, France, Germany, Japan, Netherlands, Spain, Switzerland, United Kingdom.

Quantity Affected

98 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1108-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Philips North America Llc Medical Device Recall: IntelliVue Patient Monitor MX450. Model Number: 866062 | SafeCheck