IntelliVue Patient Monitor MX500 — Class II medical device recall Z-1109-2025
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-1109-2025 |
|---|---|
| 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 | 45 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00884838038776 |
| Serial numbers | DE32300881, DE32300882, DE32300883, DE32300936, DE32300937, DE32301099, DE35114606, DE35114607, DE35133301, DE351C8908, DE351C8909, DE351C8910, DE351C8911, DE351C8912, DE351C8913, DE671E0964, DE671E0965, DE671E0966, DE671E0967, DE671E0968, DE671E0977, DE671E0978, DE671E0979, DE671E1003, DE671E1004 and 20 more |
| Model numbers | 866064 |
Product
IntelliVue Patient Monitor MX500. Model Number: 866064
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-1109-2025. 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.