FDA Device recall Z-1106-2025

IntelliBridge EC10 Module

FDA Device
Class II
ongoing
Published 2025-02-12

On 2025-02-12 the FDA classified a Class II recall of IntelliBridge EC10 Module by Philips North America, citing 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.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1106-2025
Classification	Class II
Status	ongoing
Initiated	2025-01-15
Published	2025-02-12
Last updated	2026-09-13 11:57 UTC
Company	Philips North America
Distribution	FL, NC

Product

IntelliBridge EC10 Module. Model Number: 865115

Reason

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.

Identifiers

code_info	Model Number: 865115. UDI-DI Number: (01)00884838015951(21). Serial Numbers: DE57029003, DE57028993, DE57028976, DE5702… 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,

code_info

Model Number: 865115. UDI-DI Number: (01)00884838015951(21). Serial Numbers: DE57029003, DE57028993, DE57028976, DE5702…

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,

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1106-2025%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.