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Philips North America Llc recalls IntelliVue Patient Monitor MX400. Model Number: 866060
Recalled February 12, 2025 · FDA recall Z-1107-2025 · Philips North America
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. · FDA Class II
Units
28 units
Sold at
US distribution to Florida, North Carolina, and Oregan. International distribution to Canada, Estonia, France, Germany, Japan, Netherlands, Spain, Switzerland, United Kingdom.
Description
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.
Product
IntelliVue Patient Monitor MX400. Model Number: 866060
Manufacturer(s)
Philips North America Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →