# FDA recall Z-0592-2019

> **Philips Electronics North  America Corporation** · Class II · device recall initiated 2018-10-10.

## Product

IntelliVue MX40 Patient Monitor, Model Nos. 865350, 865351, 865352, 867146 - Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. 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

A problem has been detected in the Philips IntelliVue MX4O that, if it were to occur, could affect the  performance of the equipment. The volume of the MX4O speaker in these devices may be diminished or not audible above 4,500 feet when operating in Monitor Mode. These devices may  intermittently exhibit  Speaker Malfunct  INOP messages after the Power On  Self-Test.  The issue is only apparent when the device is being used in Monitor Mode at an  altitude of greater than 4,500 feet.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0592-2019
- **Recalling firm:** Philips Electronics North  America Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2018-10-10
- **Report date:** 2018-12-19

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0592-2019

## Citation

> AI Analytics. FDA recall Z-0592-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0592-2019. Source: US FDA. Licensed CC0.

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