# FDA recall Z-1671-2021

> **Philips North America Llc** · Class II · device recall initiated 2021-02-02.

## 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

## Distribution

Worldwide distribution - US Nationwide distribution in the states of IN, MN and the country of Italy.

## Key facts

- **Recall number:** Z-1671-2021
- **Recalling firm:** Philips North America Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-02-02
- **Report date:** 2021-06-02
- **Termination date:** 2022-09-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cambridge, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1671-2021

## Citation

> AI Analytics. FDA recall Z-1671-2021. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/Z-1671-2021. Source: US FDA. Licensed CC0.

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