IntelliVue Patient Monitor MX550 — Class II medical device recall Z-1110-2025
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-1110-2025 |
|---|---|
| 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 | 74 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00884838038783 |
| Serial numbers | DE32301002, DE32301003, DE32301004, DE32302561, DE32302562, DE35114608, DE35114609, DE35186938, DE35186939, DE35186940, DE35186941, DE35186942, DE35186943, DE35186944, DE35186945, DE35186947, DE35186948, DE35186949, DE35186967, DE35186982, DE35199396, DE35199398, DE35199428, DE671E2030, DE671E2988 and 49 more |
| Model numbers | 866066 |
Product
IntelliVue Patient Monitor MX550. Model Number: 866066
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-1110-2025. 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.