FDA-Device2025-02-12Class II

IntelliVue Patient Monitor MX450. Model Number: 866062

Hazard

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.

Sold states
US distribution to Florida, North Carolina, and Oregan. International distribution to Canada, Estonia, France, Germany, Japan, Netherlands, Spain, Switzerland, United Kingdom.
Affected count
98 units
Manufactured in
222 Jacobs St, Cambridge, MA, United States
Products
IntelliVue Patient Monitor MX450. Model Number: 866062

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1108-2025

More Philips North America Llc recalls

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief