IntelliVue Patient Monitor MX450 — Class II medical device recall Z-1108-2025
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-1108-2025 |
|---|---|
| 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 | 98 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00884838038769, 00884838045859 |
| Serial numbers | DE32301476, DE32301477, DE32301478, DE32301479, DE32301480, DE32301481, DE32301482, DE32301483, DE32301484, DE32301485, DE32301486, DE32301487, DE32301488, DE32301489, DE32301490, DE32301491, DE32301506, DE32302479, DE32302480, DE32303399, DE32306016, DE32306017, DE32306018, DE32306956, DE35114612 and 73 more |
| Model numbers | 866062 |
Product
IntelliVue Patient Monitor MX450. Model Number: 866062
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-1108-2025. 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.