Medical device recalls Moderate risk

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

Recall date
January 15, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1106-2025
FDA classification
Class II
Brand / firm
Philips North America Llc
Sold / distributed
US distribution to Florida, North Carolina, and Oregan. International distribution to Canada, Estonia, France, Germany, Japan, Netherlands, Spain, Switzerland, United Kingdom.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

IntelliBridge EC10 Module. Model Number: 865115

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