FDA-Device2025-02-12Class II
IntelliVue Patient Monitor MX400. Model Number: 866060
Philips North America Llc
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
28 units
Manufactured in
222 Jacobs St, Cambridge, MA, United States
Products
IntelliVue Patient Monitor MX400. Model Number: 866060
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1107-2025Don't want to check this manually?
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