IntelliBridge EC10 Module — Class II medical device recall Z-1106-2025
Ongoing recall by Philips North America Llc, reported 2025-02-12, distributed in FL, NC. Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disco
| Recall number | Z-1106-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America Llc, Cambridge, MA, United States |
| Recall initiated | 2025-01-15 |
| Classified | 2025-02-05 |
| Reported by FDA | 2025-02-12 |
| Distributed | FL, NC |
| Countries outside the US | CA, CH, DE, EE, ES, FR, GB, JP, NL |
| Quantity | 2,230 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00884838015951 |
| Serial numbers | DE31713144, DE31713342, DE31713520, DE31714189, DE31714198, DE31714245, DE31714392, DE31714398, DE31714405, DE31714420, DE31714532, DE31714533, DE31714534, DE31714535, DE31714537, DE31714539, DE31714540, DE31714542, DE31714543, DE31714544, DE31714545, DE31714546, DE31714547, DE31714548, DE31714549 and 475 more |
| Model numbers | 865115 |
Product
IntelliBridge EC10 Module. Model Number: 865115
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1106-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.