FDA recall Z-1107-2025

Philips North America Llc · Class II · device

Product

IntelliVue Patient Monitor MX400. Model Number: 866060

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.

Key facts

Status: Ongoing
Initiation date: 2025-01-15
Report date: 2025-02-12
Voluntary/Mandated: Voluntary: Firm initiated
Location: Cambridge, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1107-2025