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

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.

Details from the source

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: 2,230 units Lot/code info: Model Number: 865115. UDI-DI Number: (01)00884838015951(21). Serial Numbers: DE57029003, DE57028993, DE57028976, DE57028982, DE57028983, DE57028987, DE57028988, DE57028951, DE57028992, DE57029001, DE57029002, DE57028989, DE57028990, DE57028991, DE57029000, DE61951169, DE61951170, DE61951171, DE61951143, DE61951141, DE61951139, DE61951172, DE61951173, DE61951193, DE61951096, DE70164542, DE70164538, DE70164539, DE70164540, DE70169842, DE70169843, DE70169846, DE70175669, DE57034208, DE57034005, DE57034248, DE57034244, DE57034243, DE57034241, DE57034237, DE57034234, DE57034231, DE57034261, DE57034245, DE57034238, DE57034229, DE57034220, DE57034030, DE57034188, DE57034679, DE57034671, DE73784113, DE73784325, DE73784414, DE73784137, DE70171598, DE70171596, DE70171601, DE70171602, DE70171597, DE70171594, DE73784927, DE73784925, DE73784924, DE73784923, DE73784922, DE73784856, DE73784926, DE31718527, DE31718491, DE31718489, DE31723270, DE31723263, DE31723264, DE31723266, DE31723271, DE31723272, DE31723273, DE31723279, DE31723277, DE31723278, DE31723280, DE31723274, DE31723319, DE31723329, DE31723328, DE31723323, DE31723320, DE31723322, DE31723338, DE31723340, DE31723312, DE31723325, DE31723327, DE31723342, DE31723294, DE31723315, DE31723316, DE31723341, DE31723331, DE31723332, DE31723330, DE31723334, DE31723318, DE31723317, DE31723313, DE31723295, DE31723293, DE31723292, DE31723291, DE31723290, DE31723289, DE31723288, DE31723287, DE31723286, DE31723379, DE31723333, DE31723337, DE31723

UPC codes

00884838015951

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.