# FDA recall Z-0544-2021

> **Philips North America Llc** · Class II · device recall initiated 2020-11-18.

## Product

Philips IntelliVue X2 Multi measurement Server: M3002A (865039) - Product Usage: intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment and during patient transport inside and outside of the hospital environment.

## Reason for recall

Speakers on IntelliVue X2 and IntelliVue MP2 may fail,  identified by the display of a  Speaker Malfunct.  INOP or by the absence of audible sound, may result in delayed treatment of the patient.

## Distribution

Worldwide distribution - US Nationwide distribution in the state of SD and the countries of China, England, Germany, Hong Kong, Portugal.

## Key facts

- **Recall number:** Z-0544-2021
- **Recalling firm:** Philips North America Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-11-18
- **Report date:** 2020-12-16
- **Termination date:** 2021-07-22

- **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-0544-2021

## Citation

> AI Analytics. FDA recall Z-0544-2021. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/Z-0544-2021. Source: US FDA. Licensed CC0.

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