IntelliVue MX40 Patient Monitor — Class II medical device recall Z-1671-2021
Terminated recall by Philips North America Llc, reported 2021-06-02, distributed nationwide. Manufacturing failed to follow process steps resulting in the distribution of potentially defective devices
| Recall number | Z-1671-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America Llc, Cambridge, MA, United States |
| Recall initiated | 2021-02-02 |
| Classified | 2021-05-21 |
| Reported by FDA | 2021-06-02 |
| Terminated | 2022-09-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | IT |
| Quantity | 3 units |
| UPC / GTIN / UDI-DI | 00884838030350, 00884838082236 |
| Serial numbers | US09699788 |
| Model numbers | 865350 |
Product
IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Software version number B.06.59 - Product Usage: Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals.
Reason for recall
Manufacturing failed to follow process steps resulting in the distribution of potentially defective devices
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-1671-2021. 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.