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Philips North America Llc recalls IntelliBridge EC10 Module. Model Number: 865115

Recalled February 12, 2025 · FDA recall Z-1106-2025 · 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
2,230 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
IntelliBridge EC10 Module. Model Number: 865115
Manufacturer(s)
Philips North America Llc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov