Class II
Medical Device Recall: IntelliVue Patient Monitor MX400. Model Number: 866060
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
28 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1107-2025
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.