FDA-Device2025-02-12Class II
IntelliBridge EC10 Module. Model Number: 865115
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
2,230 units
Manufactured in
222 Jacobs St, Cambridge, MA, United States
Products
IntelliBridge EC10 Module. Model Number: 865115
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1106-2025Don't want to check this manually?
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