IntelliVue Patient Monitor MX400 — Class II medical device recall Z-1107-2025
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-1107-2025 |
|---|---|
| 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 | 28 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00884838038752 |
| Serial numbers | DE35107369, DE35108320, DE35114616, DE35114618, DE35123130, DE35160410, DE35160988, DE35160989, DE35160994, DE35161272, DE35161273, DE35161274, DE35174080, DE35174082, DE35174083, DE35174084, DE35174105, DE671E8917, DE671E8921, DE671M4116, DE671V9296, DE671V9297, DE671V9298, DE7580AH50, DE7580AHEH and 3 more |
| Model numbers | 866060 |
Product
IntelliVue Patient Monitor MX400. Model Number: 866060
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-1107-2025. 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.