IntelliVue Patient Monitor MX400 — Class II medical device recall Z-3249-2024
Ongoing recall by Philips North America, reported 2024-10-02, distributed nationwide. During a production process, Philips became aware of one IntelliVue power supply with a broken ground bolt upo
| Recall number | Z-3249-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America, Cambridge, MA, United States |
| Recall initiated | 2024-08-30 |
| Classified | 2024-09-25 |
| Reported by FDA | 2024-10-02 |
| Distributed | Nationwide (US) |
| Quantity | 545 devices |
| UPC / GTIN / UDI-DI | 00884838038752, 00884838038769, 00884838038776, 00884838038783, 00884838057562 |
| Model numbers | 866060, 866061, 866062, 866064, 866066 |
Product
IntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 866061), MX450 (Model Number 866062), MX500 (Model Number 866064), and MX550 (Model Number 866066)
Reason for recall
During a production process, Philips became aware of one IntelliVue power supply with a broken ground bolt upon disconnection of the ground cable from the equipotential ground connector. Loss of electrical grounding may negatively affect the devices electromagnetic immunity and emission.
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-3249-2024. 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.